Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00129129
• Collaborator: (none)
• Enrollment: 756
• Locations: 27
• Arms: 5
• Duration (Months): 19.9
• Patients Per Site: 28
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.

The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

Condition or Disease	Intervention/Treatment	Phase
Haemophilus Influenzae Type b; Neisseria Meningitidis	Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; Biological: ActHIB; Biological: Pediarix; Biological: Prevnar; Biological: Menomune	Phase 2

Detailed Description

The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.

All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.

MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Design

• Study Type: Interventional
• Actual Enrollment: 756 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Sep 15, 2005
• Actual Study Completion Date: Mar 29, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MenHibrix Group Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; Primary phase: 3 IM doses Booster phase: 1 IM dose; Biological: Pediarix; Primary phase: 3 IM doses; Biological: Prevnar; Primary phase: 3 IM doses Booster phase: 1 IM dose
Active Comparator: ActHIB Group During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Biological: ActHIB; Primary phase: 3 IM doses Booster phase: 1 IM dose; Biological: Pediarix; Primary phase: 3 IM doses; Biological: Prevnar; Primary phase: 3 IM doses Booster phase: 1 IM dose
Active Comparator: Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.	Biological: Pediarix; Primary phase: 3 IM doses; Biological: Prevnar; Primary phase: 3 IM doses Booster phase: 1 IM dose; Biological: Menomune; Primary phase: 1 SC dose
Experimental: ActHIB/Menhibrix Group Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Biological: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; Primary phase: 3 IM doses Booster phase: 1 IM dose; Biological: ActHIB; Primary phase: 3 IM doses Booster phase: 1 IM dose; Biological: Pediarix; Primary phase: 3 IM doses; Biological: Prevnar; Primary phase: 3 IM doses Booster phase: 1 IM dose
Experimental: ActHIB/ActHIB Group Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Biological: ActHIB; Primary phase: 3 IM doses Booster phase: 1 IM dose; Biological: Pediarix; Primary phase: 3 IM doses; Biological: Prevnar; Primary phase: 3 IM doses Booster phase: 1 IM dose

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. [One month after the 3-dose primary vaccination course (at Month 5)]

   The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

2. Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes [One month after the 3-dose primary vaccination course (at Month 5)]

   Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

3. Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations [One month after the 3-dose primary vaccination course (at Month 5)]

   Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

4. Number of Subjects Reporting Any Grade 3 Symptoms [During the 4-day follow-up period after each primary vaccine dose]

   "Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

5. Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value [One month after the fourth dose (at Month 11-14)]

   The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .

Secondary Outcome Measures

1. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

   rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.

2. Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

   Titers are presented as geometric mean titers (GMTs).

3. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

   rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.

4. Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

   Titers are presented as geometric mean titers (GMTs).

5. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 [One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)]

   A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.

6. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 [One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)]

   A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.

7. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

   Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.

8. Anti-polysaccharide C (Anti-PSC) Antibody Concentrations [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

   Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).

9. Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

   Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.

10. Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations [Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)

11. Number of Subjects Reporting Medically Attended Visits [During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0]

    A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.

12. Number of Subjects Reporting Rash [During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0]

    An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.

13. Number of Subjects Reporting Serious Adverse Events (SAEs) [During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0]

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.

14. Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

15. Anti-PRP Antibody Concentrations [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

16. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

17. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups

18. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

19. Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

20. Anti-diphtheria and Anti-tetanus Antibody Concentrations [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

21. Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    This Outcome Measure only concerns the MenHibrix and ActHIB groups .

22. Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

23. Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    This Outcome Measure only concerns the MenHibrix and ActHIB groups .

24. Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations [Prior to the primary vaccination course (at Day 0)]

    Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

25. Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    This Outcome Measure only concerns the MenHibrix and ActHIB groups .

26. Anti-poliovirus Types 1, 2 and 3 Antibody Titers [Prior to and one month after the primary vaccination course (at Day 0 and Month 5)]

    Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

27. Number of Subjects With Vaccine Response to PT, FHA and PRN [One month after the 3-dose primary vaccination course (at Month 5)]

    Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

28. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms [Within 4 days (Day 0-3) after the 3-dose primary vaccination]

    Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

29. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms [Within 8 days (Day 0-7) after the 3-dose primary vaccination]

    Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

30. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms [Within 4 days (Day 0-3) after the 3-dose primary vaccination]

    Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

31. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms [Within 8 days (Day 0-7) after the 3-dose primary vaccination]

    Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups

32. Number of Subjects Reporting Unsolicited Adverse Events (AEs) [From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).]

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

33. Number of Subjects Reporting Serious Adverse Events (SAEs) [During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).]

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

34. Number of Subjects Reporting Serious Adverse Events (SAEs) [From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.]

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

35. Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs) [From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine]

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

36. Number of Subjects Reporting Rash [From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.]

    An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

37. Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses [From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.]

    Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

38. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) [One month post fourth dose vaccination (at Month 11-14)]

    Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1): Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32), Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose.

39. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) [One month post fourth dose vaccination (at Month 11-14)]

    Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2): Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8), At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128, At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128.

40. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) [One month post fourth dose vaccination (at Month 11-14)]

    Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1): Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16), Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose.

41. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) [One month post fourth dose vaccination (at Month 11-14)]

    Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2): Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8), At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8, At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8.

42. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) [One month after fourth dose vaccination (at Month 11-14)]

    Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

43. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) [One month after fourth dose vaccination (at Month 11-14)]

    Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

44. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) [One month after fourth dose vaccination (at Month 11-14)]

    Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

45. Concentration of Antibodies Against Streptococcus Pneumonia Serotypes [One month post fourth dose vaccination (at Month 11-14)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

46. Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.

47. Anti-PRP Antibody Concentrations [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)

48. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128

49. rSBA-MenC Antibody Titers [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Titers are presented as geometric mean titers (GMTs).

50. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.

51. rSBA-MenY Antibody Titers [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Titers are presented as geometric mean titers (GMTs).

52. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.

53. hSBA-MenC Antibody Titers [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Titers are presented as geometric mean titers (GMTs).

54. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.

55. hSBA-MenY Antibody Titers [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Titers are presented as geometric mean titers (GMTs).

56. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.

57. Anti-PSC Antibody Concentrations [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).

58. Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.

59. Anti-PSY Antibody Concentrations [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)

60. Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

61. Anti-tetanus Antibody Concentrations [Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)]

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).

62. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms [Within 4 days (Day 0-3) after fourth dose vaccination]

    Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm

63. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms [Within 8 days (Day 0-7) after fourth dose vaccination]

    Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm

64. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms [Within 4 days (Day 0-3) after fourth dose vaccination]

    Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C

65. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms [Within 8 days (Day 0-7) after fourth dose vaccination]

    Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C

66. Number of Subjects Reporting Unsolicited Adverse Events (AEs) [During the 31-day follow-up period following the fourth dose]

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

67. Number of Subjects Reporting New Onset of Chronic Illness(es) [From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up]

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

68. Number of Subjects Reporting Rash [From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up]

    An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.

69. Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses [From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up]

    Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

70. Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) [Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose]

    Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 15 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• For Groups A and B

• Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.

• Healthy male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.

• Written informed consent obtained from the parent or guardian of the subject.

• Free of obvious health problems as established by medical history and clinical examination before entering the study.

• Born after a gestation period between 36 and 42 weeks.

• Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.

• For Group C

• Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.

• Healthy male or female between, and including, 3 and 5 years of age at the time of the first vaccination.

• Written informed consent obtained from the parent or guardian of the subject.

• Free of obvious health problems as established by medical history and clinical examination before entering the study.

Exclusion Criteria:

-For Groups A and B

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).

• Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.

• History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber.

• Major congenital defects or serious chronic illness.

• History of any neurologic disorders or seizures.

• Acute disease at time of enrollment.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

For Group C

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.

• Previous vaccination against Neisseria meningitidis.

• History of Neisseria meningitidis disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including dry natural latex rubber

• Major congenital defects or serious chronic illness.

• Acute disease at time of enrollment.

• Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Little Rock	Arkansas	United States	72205
2	GSK Investigational Site	Fountain Valley	California	United States	92708
3	GSK Investigational Site	Centennial	Colorado	United States	80112
4	GSK Investigational Site	Norwich	Connecticut	United States	06360
5	GSK Investigational Site	Marietta	Georgia	United States	30062
6	GSK Investigational Site	Des Moines	Iowa	United States	50266
7	GSK Investigational Site	Bardstown	Kentucky	United States	40004
8	GSK Investigational Site	Louisville	Kentucky	United States	40202
9	GSK Investigational Site	Louisville	Kentucky	United States	40272
10	GSK Investigational Site	Bossier City	Louisiana	United States	71111
11	GSK Investigational Site	Boston	Massachusetts	United States	02115
12	GSK Investigational Site	Boston	Massachusetts	United States	02118
13	GSK Investigational Site	New Bedford	Massachusetts	United States	02740
14	GSK Investigational Site	Bronx	New York	United States	10467
15	GSK Investigational Site	Rochester	New York	United States	14620
16	GSK Investigational Site	Boardman	Ohio	United States	44512
17	GSK Investigational Site	University Heights	Ohio	United States	44118
18	GSK Investigational Site	Beaver Falls	Pennsylvania	United States	15010
19	GSK Investigational Site	Erie	Pennsylvania	United States	16505
20	GSK Investigational Site	Greenville	Pennsylvania	United States	16125
21	GSK Investigational Site	Norristown	Pennsylvania	United States	19401
22	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15217
23	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15227
24	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15236
25	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15241
26	GSK Investigational Site	Rydal	Pennsylvania	United States	19046
27	GSK Investigational Site	Warwick	Rhode Island	United States	02886

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. Review.
• Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, Boutriau D; HibMenCY-TT 005 Study Group. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 2010 Jan;29(1):48-52. doi: 10.1097/INF.0b013e3181c3ce88.
• Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
• Marshall GS, Marchant CD, Blatter M, Friedland LR, Aris E, Miller JM. Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Hum Vaccin. 2011 Feb;7(2):258-64. Epub 2011 Feb 1.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00129129
• Other Study ID Numbers: 101858; 102015
• First Posted: Aug 11, 2005
• Last Update Posted: Aug 24, 2018
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Immunogenicity; Primary & booster vaccination; Infants; Meningococcal vaccine; Safety; Children; Hib disease; Meningococcal disease
• Additional relevant MeSH terms: Vaccines

Study Results

Participant Flow

Recruitment Details	In a Primary Phase (study 101858), 3 groups, MenHibrix, ActiHIB and Menomune, were followed from Day 0 to either Month (M) 7 or 10, depending on vaccination. Then, in a Fourth-Dose Phase (study 102015), 3 groups (MenHibrix, ActiHIB/ActHIB and ActiHIB/MenHibrix) were followed from M10-13 to study end (M16-19). Treatment allocation: primary phase:
Pre-assignment Detail	MenHibrix Group was followed during the entire study period, from Day 0 to M16-19). ActiHIB Group was followed as ActiHIB Group up to M10-13, when it was split into the ActHIB/ActHIB and ActHIB/MenHibrix groups, these latter being followed from M10-13 to study end. Menomune Group was followed up to M7.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group	ActHIB/MenHibrix Group	ActHIB/ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.	Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Period Title: Primary Phase
STARTED	287	319	150	0	0
COMPLETED	262	294	150	0	0
NOT COMPLETED	25	25	0	0	0
Period Title: Primary Phase
STARTED	236	0	0	132	130
COMPLETED	232	0	0	128	124
NOT COMPLETED	4	0	0	4	6

Baseline Characteristics

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group	Total
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh..	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.	Total of all reporting groups
Overall Participants	287	319	150	756
Age (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	64.2 (8.05)	64.0 (7.52)	1554.1 (338.4)	560.8 (118.0)
Sex: Female, Male (Count of Participants)
Female	141 49.1%	166 52%	70 46.7%	377 49.9%
Male	146 50.9%	153 48%	80 53.3%	379 50.1%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.
Description	The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	One month after the 3-dose primary vaccination course (at Month 5)

Outcome Measure Data

Analysis Population Description

The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	199	211
Count of Participants [Participants]	186 64.8%	181 56.7%

2. Primary Outcome

Title	Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	One month after the 3-dose primary vaccination course (at Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	174	180
Anti-4 (N=173;177)	1.72	1.9
Anti-6B (N=166;162)	1.31	1.59
Anti-9V (N=174;180)	2.17	2.32
Anti-14 (N=167;172)	4.79	4.64
Anti-18C (N=172;169)	2.5	2.56
Anti-19F (N=167;169)	1.62	1.74
Anti-23F (N=174;177)	2.25	2.46

3. Primary Outcome

Title	Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	One month after the 3-dose primary vaccination course (at Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	200	217
Anti-PT (N=198;215)	57.1	66.4
Anti-FHA (N=200;213)	208.9	252.2
Anti-PRN (N=200;217)	86.3	93.8

4. Primary Outcome

Title	Number of Subjects Reporting Any Grade 3 Symptoms
Description	"Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	During the 4-day follow-up period after each primary vaccine dose

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	287	319
Count of Participants [Participants]	33 11.5%	79 24.8%

5. Primary Outcome

Title	Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value
Description	The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .
Time Frame	One month after the fourth dose (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	176	93
Count of Participants [Participants]	174 60.6%	92 28.8%

6. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values
Description	rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	177	194	136
≥1:8 [Prior to vaccination] (N=153;183;133)	10 3.5%	13 4.1%	27 18%
≥1:128 [Prior to vaccination] (N=153;183;133)	3 1%	5 1.6%	20 13.3%
≥1:8 [1 month post-vaccination] (N=177;194;136)	173 60.3%	7 2.2%	126 84%
≥1:128 [1 month post-vaccination] (N=177;194;136)	171 59.6%	2 0.6%	105 70%

7. Secondary Outcome

Title	Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	177	194	136
[Prior to vaccination] (N=153;183;133)	4.8	5.1	9
[1 month post-vaccination] (N=177;194;136)	1096.5	4.4	284.2

8. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values
Description	rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	174	186	140
≥1:8 [Prior to vaccination] (N=156;186;140)	29 10.1%	28 8.8%	92 61.3%
≥1:128 [Prior to vaccination] (N=156;186;140)	4 1.4%	3 0.9%	61 40.7%
≥1:8 [1 month post-vaccination] (N=174;186;139)	171 59.6%	35 11%	134 89.3%
≥1:128 [1 month post-vaccination] (N=174;186;139)	154 53.7%	6 1.9%	131 87.3%

9. Secondary Outcome

Title	Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	174	186	140
[prior to vaccination] (N=156;186;140)	6.1	5.7	54.9
[1 month post-vaccination] (N=174;186;139)	495.3	6.8	685.1

10. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
Description	A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.
Time Frame	One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	177	22	136
Count of Participants [Participants]	2 0.7%	1 0.3%	3 2%

11. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
Description	A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.
Time Frame	One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	174	22	139
Count of Participants [Participants]	13 4.5%	0 0%	0 0%

12. Secondary Outcome

Title	Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values
Description	Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	197	207	138
≥0.3 µg/mL [prior to vaccination] (N=161;185;138)	24 8.4%	16 5%	10 6.7%
≥0.3 µg/mL [after vaccination] (N=197;207;136)	196 68.3%	8 2.5%	134 89.3%
≥2.0 µg/mL [prior to vaccination] (N=161;185;138)	1 0.3%	6 1.9%	3 2%
≥2.0 µg/mL [after vaccination] (N=197;207;136)	172 59.9%	0 0%	122 81.3%

13. Secondary Outcome

Title	Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	197	207	138
[prior to vaccination] (N=161;185;138)	0.19	0.18	0.17
[1 month post-vaccination] (N=197;207;136)	4.41	0.16	7.37

14. Secondary Outcome

Title	Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values
Description	Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	189	187	137
≥0.3 µg/mL [prior to vaccination] (N=157;187;137)	23 8%	28 8.8%	6 4%
≥0.3 µg/mL [after vaccination] (N=189;181;129)	188 65.5%	5 1.6%	125 83.3%
≥2.0 µg/mL [prior to vaccination] (N=157;187;137)	5 1.7%	6 1.9%	2 1.3%
≥2.0 µg/mL [after vaccination] (N=189;181;129)	186 64.8%	0 0%	108 72%

15. Secondary Outcome

Title	Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	189	187	137
[prior to vaccination] (N=157;187;137)	0.20	0.20	0.17
[1 month post-vaccination] (N=189;181;129)	19.82	0.15	7.21

16. Secondary Outcome

Title	Number of Subjects Reporting Medically Attended Visits
Description	A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.
Time Frame	During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	Menomune Group
Arm/Group Description	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	150
Emergency room visit	1 0.3%
Physician's office visit	18 6.3%

17. Secondary Outcome

Title	Number of Subjects Reporting Rash
Description	An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.
Time Frame	During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	Menomune Group
Arm/Group Description	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	150
Count of Participants [Participants]	1 0.3%

18. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.
Time Frame	During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	Menomune Group
Arm/Group Description	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	150
Count of Participants [Participants]	0 0%

19. Secondary Outcome

Title	Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values
Description	Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	199	211
≥0.15 µg/mL [prior to vaccination] (N=112;132)	43 15%	42 13.2%
≥0.15 µg/mL [after vaccination] (N=199;211)	196 68.3%	202 63.3%
≥1.0 µg/mL [prior to vaccination] (N=112;132)	9 3.1%	10 3.1%
≥1.0 µg/mL [after vaccination] (N=199;211)	186 64.8%	181 56.7%

20. Secondary Outcome

Title	Anti-PRP Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	199	211
[prior to vaccination] (N=112;132)	0.155	0.142
[1 month post-vaccination] (N=199;211)	7.992	4.392

21. Secondary Outcome

Title	Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
Description	The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	174	180
Anti-4 [prior to vaccination] (N=87;100)	23 8%	18 5.6%
Anti-4 [after vaccination] (N=173;177)	173 60.3%	177 55.5%
Anti-6B [prior to vaccination] (N=84;96)	40 13.9%	41 12.9%
Anti-6B [after vaccination] (N=166;162)	163 56.8%	162 50.8%
Anti-9V [prior to vaccination] (N=88;100)	45 15.7%	54 16.9%
Anti-9V [after vaccination] (N=174;180)	174 60.6%	180 56.4%
Anti-14 [prior to vaccination] (N=75;90)	70 24.4%	80 25.1%
Anti-14 [after vaccination] (N=167;172)	167 58.2%	172 53.9%
Anti-18C [prior to vaccination] (N=85;97)	41 14.3%	55 17.2%
Anti-18C [after vaccination] (N=172;169)	172 59.9%	169 53%
Anti-19F [prior to vaccination] (N=88;99)	76 26.5%	82 25.7%
Anti-19F [after vaccination] (N=167;169)	167 58.2%	169 53%
Anti-23F [prior to vaccination] (N=86;103)	44 15.3%	47 14.7%
Anti-23F [after vaccination] (N=174;177)	173 60.3%	176 55.2%

22. Secondary Outcome

Title	Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
Description	The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	174	180
Anti-4 [prior to vaccination] (N=87;100)	9 3.1%	3 0.9%
Anti-4 [after vaccination] (N=173;177)	173 60.3%	177 55.5%
Anti-6B [prior to vaccination] (N=84;96)	12 4.2%	15 4.7%
Anti-6B [after vaccination] (N=166;162)	155 54%	155 48.6%
Anti-9V [prior to vaccination] (N=88;100)	19 6.6%	19 6%
Anti-9V [after vaccination] (N=174;180)	173 60.3%	180 56.4%
Anti-14 [prior to vaccination] (N=75;90)	46 16%	62 19.4%
Anti-14 [after vaccination] (N=167;172)	166 57.8%	171 53.6%
Anti-18C [prior to vaccination] (N=85;97)	19 6.6%	24 7.5%
Anti-18C [after vaccination] (N=172;169)	172 59.9%	167 52.4%
Anti-19F [prior to vaccination] (N=88;99)	47 16.4%	52 16.3%
Anti-19F [after vaccination] (N=167;169)	166 57.8%	169 53%
Anti-23F [prior to vaccination] (N=86;103)	13 4.5%	15 4.7%
Anti-23F [after vaccination] (N=174;177)	171 59.6%	174 54.5%

23. Secondary Outcome

Title	Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
Description	The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	174	180
Anti-4 [prior to vaccination] (N=87;100)	1 0.3%	0 0%
Anti-4 [after vaccination] (N=173;177)	162 56.4%	168 52.7%
Anti-6B [prior to vaccination] (N=84;96)	10 3.5%	8 2.5%
Anti-6B [after vaccination] (N=166;162)	130 45.3%	139 43.6%
Anti-9V [prior to vaccination] (N=88;100)	5 1.7%	9 2.8%
Anti-9V [after vaccination] (N=174;180)	169 58.9%	175 54.9%
Anti-14 [prior to vaccination] (N=75;90)	32 11.1%	33 10.3%
Anti-14 [after vaccination] (N=167;172)	164 57.1%	167 52.4%
Anti-18C [prior to vaccination] (N=85;97)	5 1.7%	8 2.5%
Anti-18C [after vaccination] (N=172;169)	168 58.5%	166 52%
Anti-19F [prior to vaccination] (N=88;99)	27 9.4%	20 6.3%
Anti-19F [after vaccination] (N=167;169)	156 54.4%	160 50.2%
Anti-23F [prior to vaccination] (N=86;103)	7 2.4%	8 2.5%
Anti-23F [after vaccination] (N=174;177)	155 54%	167 52.4%

24. Secondary Outcome

Title	Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)
Description	The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	201	220
Anti-diphtheria [prior to vaccination] (N=118;140)	81 28.2%	89 27.9%
Anti-diphtheria [after vaccination] (N=201;220)	201 70%	219 68.7%
Anti-tetanus [prior to vaccination] (N=118;139)	109 38%	130 40.8%
Anti-tetanus [after vaccination] (N=199;216)	198 69%	216 67.7%

25. Secondary Outcome

Title	Anti-diphtheria and Anti-tetanus Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	201	220
Anti-diphtheria [prior to vaccination] (N=118;140)	0.173	0.155
Anti-diphtheria [after vaccination] (N=201;220)	2.060	2.277
Anti-tetanus [prior to vaccination] (N=118;139)	0.565	0.497
Anti-tetanus [after vaccination] (N=199;216)	3.618	1.986

26. Secondary Outcome

Title	Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)
Description	This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	171	169
[prior to vaccination] (N=91;108)	28 9.8%	27 8.5%
[after vaccination] (N=171;169)	167 58.2%	166 52%

27. Secondary Outcome

Title	Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	171	169
[prior to vaccination] (N=91;108)	13.5	11.3
[after vaccination] (N=171;169)	1567.5	1555.1

28. Secondary Outcome

Title	Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL
Description	This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	200	217
Anti-PT [prior to vaccination] (N=116;140)	21 7.3%	37 11.6%
Anti-PT [after vaccination] (N=198;215)	196 68.3%	214 67.1%
Anti-FHA [prior to vaccination] (N=118;140)	91 31.7%	103 32.3%
Anti-FHA [after vaccination] (N=200;213)	200 69.7%	213 66.8%
Anti-PRN [prior to vaccination] (N=117;139)	40 13.9%	56 17.6%
Anti-PRN [after vaccination] (N=200;217)	199 69.3%	215 67.4%

29. Secondary Outcome

Title	Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description	Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to the primary vaccination course (at Day 0)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	118	140
Anti-PT [prior to vaccination] (N=116;140)	3.4	3.9
Anti-FHA [prior to vaccination] (N=118;140)	10.0	10.5
Anti-PRN [prior to vaccination] (N=117;139)	4.8	5.1

30. Secondary Outcome

Title	Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8
Description	This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	91	83
Anti-polio 1 [prior to vaccination] (N=61;60)	34 11.8%	41 12.9%
Anti-polio 1 [after vaccination] (N=87;82)	86 30%	82 25.7%
Anti-polio 2 [prior to vaccination] (N=60;63)	31 10.8%	39 12.2%
Anti-polio 2 [after vaccination] (N=91;83)	91 31.7%	82 25.7%
Anti-polio 3 [prior to vaccination] (N=61;64)	7 2.4%	13 4.1%
Anti-polio 3 [after vaccination] (N=84;79)	84 29.3%	79 24.8%

31. Secondary Outcome

Title	Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Description	Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	91	83
Anti-polio 1 [prior to vaccination] (N=61;60)	12.3	17.3
Anti-polio 1 [after vaccination] (N=87;82)	530.7	651.5
Anti-polio 2 [prior to vaccination] (N=60;63)	9.4	13.5
Anti-polio 2 [after vaccination] (N=91;83)	398.2	330.4
Anti-polio 3 [prior to vaccination] (N=61;64)	4.7	6.2
Anti-polio 3 [after vaccination] (N=84;79)	923.7	1055.8

32. Secondary Outcome

Title	Number of Subjects With Vaccine Response to PT, FHA and PRN
Description	Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	One month after the 3-dose primary vaccination course (at Month 5)

Outcome Measure Data

Analysis Population Description

The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	116	135
Anti-PT (N=111;135)	109 38%	132 41.4%
Anti-FHA (N=116;132)	113 39.4%	128 40.1%
Anti-PRN (N=115;133)	103 35.9%	126 39.5%

33. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Description	Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Within 4 days (Day 0-3) after the 3-dose primary vaccination

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	286	317
Any pain	129 44.9%	171 53.6%
Grade 2 or 3 pain	62 21.6%	90 28.2%
Grade 3 pain	13 4.5%	31 9.7%
Any redness	112 39%	148 46.4%
Redness >10 mm	22 7.7%	31 9.7%
Redness >30 mm	1 0.3%	11 3.4%
Any swelling	90 31.4%	110 34.5%
Swelling >10 mm	27 9.4%	27 8.5%
Swelling >30 mm	1 0.3%	11 3.4%

34. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Description	Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Within 8 days (Day 0-7) after the 3-dose primary vaccination

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	286	317
Any pain	129 44.9%	171 53.6%
Grade 2 or 3 pain	63 22%	90 28.2%
Grade 3 pain	13 4.5%	31 9.7%
Any redness	113 39.4%	148 46.4%
Redness >10 mm	22 7.7%	31 9.7%
Redness >30 mm	1 0.3%	11 3.4%
Any swelling	90 31.4%	111 34.8%
Swelling >10 mm	27 9.4%	27 8.5%
Swelling >30 mm	1 0.3%	11 3.4%

35. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Description	Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	Within 4 days (Day 0-3) after the 3-dose primary vaccination

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	286	317
Any drowsiness	185 64.5%	224 70.2%
Grade 2 or 3 drowsiness	84 29.3%	112 35.1%
Grade 3 drowsiness	9 3.1%	20 6.3%
Fever ≥38.0°C	110 38.3%	150 47%
Fever >39.0°C	14 4.9%	13 4.1%
Fever >40.0°C	0 0%	0 0%
Any irritability	217 75.6%	268 84%
Grade 2 or 3 irritability	125 43.6%	161 50.5%
Grade 3 irritability	22 7.7%	48 15%
Any loss of appetite	123 42.9%	159 49.8%
Grade 2 or 3 loss of appetite	32 11.1%	51 16%
Grade 3 loss of appetite	3 1%	4 1.3%

36. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Description	Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups
Time Frame	Within 8 days (Day 0-7) after the 3-dose primary vaccination

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	286	317
Any drowsiness	187 65.2%	227 71.2%
Grade 2 or 3 drowsiness	85 29.6%	116 36.4%
Grade 3 drowsiness	10 3.5%	21 6.6%
Fever ≥38.0°C	115 40.1%	158 49.5%
Fever >39.0°C	19 6.6%	19 6%
Fever >40.0°C	0 0%	0 0%
Any irritability	222 77.4%	272 85.3%
Grade 2 or 3 irritability	127 44.3%	168 52.7%
Grade 3 irritability	25 8.7%	51 16%
Any loss of appetite	127 44.3%	164 51.4%
Grade 2 or 3 loss of appetite	35 12.2%	56 17.6%
Grade 3 loss of appetite	4 1.4%	5 1.6%

37. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame	From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	287	319	150
Count of Participants [Participants]	213 74.2%	230 72.1%	37 24.7%

38. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame	During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group	Menomune Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.	Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Measure Participants	287	319	150
Count of Participants [Participants]	16 5.6%	20 6.3%	0 0%

39. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	287	319
Count of Participants [Participants]	16 5.6%	20 6.3%

40. Secondary Outcome

Title	Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)
Description	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	287	319
Count of Participants [Participants]	2 0.7%	5 1.6%

41. Secondary Outcome

Title	Number of Subjects Reporting Rash
Description	An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time Frame	From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	287	319
Count of Participants [Participants]	50 17.4%	55 17.2%

42. Secondary Outcome

Title	Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses
Description	Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Time Frame	From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
Measure Participants	287	319
Emergency room visit	25 8.7%	31 9.7%
Physician's office visit	181 63.1%	190 59.6%
Physician's o. v. not related to common illnesses	51 17.8%	46 14.4%

43. Secondary Outcome

Title	Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Description	Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1): Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32), Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose.
Time Frame	One month post fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	149	72	79
rSBA-MenC (N=149;72;77)	131 45.6%	2 0.6%	71 47.3%
rSBA-MenY (N=147;67;79)	119 41.5%	10 3.1%	76 50.7%

44. Secondary Outcome

Title	Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Description	Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2): Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8), At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128, At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128.
Time Frame	One month post fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	149	72	79
rSBA-MenC (N=149;72;77)	140 48.8%	2 0.6%	71 47.3%
rSBA-MenY (N=147;67;79)	134 46.7%	11 3.4%	78 52%

45. Secondary Outcome

Title	Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
Description	Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1): Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16), Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose.
Time Frame	One month post fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	Menhibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
Measure Participants	61	36	33
hSBA-MenC (N=58;36;33)	44 15.3%	0 0%	29 19.3%
hSBA-MenY (N=61;36;33)	52 18.1%	1 0.3%	15 10%

46. Secondary Outcome

Title	Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
Description	Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2): Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8), At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8, At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8.
Time Frame	One month post fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	61	36	33
hSBA-MenC (N=58;36;33)	52 18.1%	0 0%	29 19.3%
hSBA-MenY (N=61;36;33)	56 19.5%	1 0.3%	15 10%

47. Secondary Outcome

Title	Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)
Description	Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time Frame	One month after fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	176	90	102
Anti-4 (N=174;89;102)	174 60.6%	89 27.9%	102 68%
Anti-6B (N=174;89;101)	174 60.6%	89 27.9%	101 67.3%
Anti-9V (N=175;90;102)	175 61%	90 28.2%	102 68%
Anti-14 (N=174;87;100)	174 60.6%	87 27.3%	100 66.7%
Anti-18C (N=175;88;102)	175 61%	88 27.6%	102 68%
Anti-19F (N=173;89;96)	173 60.3%	89 27.9%	96 64%
Anti-23F (N=176;90;102)	175 61%	90 28.2%	101 67.3%

48. Secondary Outcome

Title	Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)
Description	Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time Frame	One month after fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	176	90	102
Anti-4 (N=174;89;102)	174 60.6%	89 27.9%	102 68%
Anti-6B (N=174;89;101)	174 60.6%	89 27.9%	101 67.3%
Anti-9V (N=175;90;102)	175 61%	90 28.2%	102 68%
Anti-14 (N=174;87;100)	174 60.6%	87 27.3%	100 66.7%
Anti-18C (N=175;88;102)	175 61%	88 27.6%	102 68%
Anti-19F (N=173;89;96)	171 59.6%	89 27.9%	96 64%
Anti-23F (N=176;90;102)	175 61%	90 28.2%	101 67.3%

49. Secondary Outcome

Title	Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)
Description	Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time Frame	One month after fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	176	90	102
Anti-4 (N=174;89;102)	165 57.5%	86 27%	99 66%
Anti-6B (N=174;89;101)	171 59.6%	89 27.9%	100 66.7%
Anti-9V (N=175;90;102)	174 60.6%	90 28.2%	102 68%
Anti-14 (N=174;87;100)	172 59.9%	87 27.3%	100 66.7%
Anti-18C (N=175;88;102)	174 60.6%	88 27.6%	102 68%
Anti-19F (N=173;89;96)	157 54.7%	83 26%	91 60.7%
Anti-23F (N=176;90;102)	175 61%	90 28.2%	101 67.3%

50. Secondary Outcome

Title	Concentration of Antibodies Against Streptococcus Pneumonia Serotypes
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time Frame	One month post fourth dose vaccination (at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	Menhibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	176	90	102
Anti-4 (N=174;89;102)	2.38	2.69	2.92
Anti-6B (N=174;89;101)	3.91	4.07	5.04
Anti-9V (N=175;90;102)	3.84	3.85	4.60
Anti-14 (N=174;87;100)	6.12	7.00	7.87
Anti-18C (N=175;88;102)	4.57	5.23	5.45
Anti-19F (N=173;89;96)	1.81	1.93	2.04
Anti-23F (N=176;90;102)	7.23	8.02	9.08

51. Secondary Outcome

Title	Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values
Description	Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
Measure Participants	176	93	103
≥0.15 µg/mL [pre-4th dose] (N=160;89;95)	152 53%	78 24.5%	85 56.7%
≥0.15 µg/mL [post-4th dose] (N=176;93;103)	176 61.3%	93 29.2%	103 68.7%
≥1.0 µg/mL [pre-4th dose] (N=160;89;95)	90 31.4%	41 12.9%	40 26.7%
≥1.0 µg/mL [post-4th dose] (N=176;93;103)	174 60.6%	92 28.8%	101 67.3%

52. Secondary Outcome

Title	Anti-PRP Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/Menhibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	176	93	103
[pre-fourth dose] (N=160;89;95)	1.073	0.810	0.695
[post-fourth dose] (N=176;93;103)	28.596	19.029	10.650

53. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
Description	rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	Menhibrix Group	ActHIB/ActHIB Group	ActHIB/Menhibrix Group
Arm/Group Description	Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	163	83	92
≥ 1:8 [pre-fourth dose] (N=157;83;89)	147 51.2%	5 1.6%	9 6%
≥1:8 [post-fourth dose] (N=163;82;92)	161 56.1%	8 2.5%	90 60%
≥ 1:128 [pre-fourth dose] (N=157;83;89)	104 36.2%	1 0.3%	2 1.3%
≥1:128 [post-fourth dose] (N=163;82;92)	159 55.4%	1 0.3%	74 49.3%

54. Secondary Outcome

Title	rSBA-MenC Antibody Titers
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	163	83	92
[pre-fourth dose] (N=157;83;89)	167.1	4.7	5.3
[post-fourth dose] (N=163;82;92))	2443.9	5.3	321.8

55. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
Description	rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	162	80	93
≥1:8 [pre-fourth dose] (N=158;79;90)	142 49.5%	26 8.2%	37 24.7%
≥1:8 [post-fourth dose] (N=162;80;93)	160 55.7%	30 9.4%	93 62%
≥1:128 [pre-fourth dose] (N=158;79;90)	96 33.4%	10 3.1%	17 11.3%
≥1:128 [post-fourth dose] (N=162;80;93)	158 55.1%	16 5%	92 61.3%

56. Secondary Outcome

Title	rSBA-MenY Antibody Titers
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	162	80	93
[pre-fourth dose] (N=158;79;90)	128.6	11.3	15.6
[post-fourth dose] (N=162;80;93)	1424.6	16.1	1454.0

57. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
Description	hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	65	38	35
≥1:4 [pre-fourth dose] (N=59;38;35)	54 18.8%	0 0%	1 0.7%
≥1:4 [post-fourth dose] (N=65;37;35)	63 22%	1 0.3%	33 22%
≥1:8 [pre-fourth dose] (N=59;38;35)	54 18.8%	0 0%	0 0%
≥1:8 [post-fourth dose] (N=65;37;35)	63 22%	0 0%	33 22%

58. Secondary Outcome

Title	hSBA-MenC Antibody Titers
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	65	38	35
[pre-fourth dose] (N=59;38;35)	68.1	NA	2.0
[post-fourth dose] (N=65;37;35)	657.1	2.1	72.5

59. Secondary Outcome

Title	Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
Description	hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	65	38	35
≥1:4 [pre-fourth dose] (N=62;38;35)	33 11.5%	0 0%	0 0%
≥1:4 [post-fourth dose] (N=65;37;35)	62 21.6%	1 0.3%	21 14%
≥1:8 [pre-fourth dose] (N=62;38;35)	30 10.5%	0 0%	0 0%
≥1:8 [post-fourth dose] (N=65;37;35)	62 21.6%	1 0.3%	20 13.3%

60. Secondary Outcome

Title	hSBA-MenY Antibody Titers
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	65	38	35
[pre-fourth dose] (N=62;38;35)	11.3	NA	NA
[post-fourth dose] (N=65;37;35)	246.6	2.2	11.1

61. Secondary Outcome

Title	Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values
Description	Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	174	89	104
≥0.3 µg/mL [pre-fourth dose] (N=159;89;89)	150 52.3%	3 0.9%	5 3.3%
≥0.3 µg/mL [post-fourth dose] (N=174;89;104)	173 60.3%	3 0.9%	104 69.3%
≥2.0 µg/mL [pre-fourth dose] (N=159;89;89)	20 7%	0 0%	1 0.7%
≥2.0 µg/mL [post-fourth dose] (N=174;89;104)	142 49.5%	0 0%	98 65.3%

62. Secondary Outcome

Title	Anti-PSC Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	174	89	104
[pre-fourth dose] (N=159;89;89)	0.88	0.16	0.16
[post-fourth dose] (N=174;89;104)	4.32	0.16	6.81

63. Secondary Outcome

Title	Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values
Description	Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	173	87	101
≥0.3 µg/mL [pre-fourth dose] (N=157;82;85)	155 54%	1 0.3%	0 0%
≥0.3 µg/mL [post-fourth dose] (N=173;87;101)	172 59.9%	3 0.9%	101 67.3%
≥2.0 µg/mL [pre-fourth dose] (N=157;82;85)	116 40.4%	0 0%	0 0%
≥2.0 µg/mL [post-fourth dose] (N=173;87;101)	168 58.5%	0 0%	87 58%

64. Secondary Outcome

Title	Anti-PSY Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	173	87	101
[pre-fourth dose] (N=157;82;85)	3.83	0.15	NA
[post-fourth dose] (N=173;87;101)	22.27	0.16	5.57

65. Secondary Outcome

Title	Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	178	95	104
[pre-fourth dose] (N=164;92;95)	164 57.1%	89 27.9%	93 62%
[post-fourth dose] (N=178;95;104)	178 62%	95 29.8%	104 69.3%

66. Secondary Outcome

Title	Anti-tetanus Antibody Concentrations
Description	Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).
Time Frame	Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

Outcome Measure Data

Analysis Population Description

The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	178	95	104
[pre-fourth dose] (N=164;92;95)	0.782	0.461	0.488
[post-fourth dose] (N=178;95;104)	2.559	1.785	1.794

67. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Description	Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm
Time Frame	Within 4 days (Day 0-3) after fourth dose vaccination

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	232	126	130
Any limb circumference	59 20.6%	44 13.8%	36 24%
Limb circumference >20 mm	2 0.7%	5 1.6%	5 3.3%
Limb circumference >40 mm	0 0%	0 0%	0 0%
Any pain	79 27.5%	42 13.2%	48 32%
Grade 2 or 3 pain	26 9.1%	15 4.7%	12 8%
Grade 3 pain	3 1%	2 0.6%	3 2%
Any redness	81 28.2%	40 12.5%	38 25.3%
Redness >10 mm	12 4.2%	10 3.1%	10 6.7%
Redness >30 mm	4 1.4%	3 0.9%	3 2%
Any swelling	49 17.1%	19 6%	20 13.3%
Swelling >10 mm	9 3.1%	1 0.3%	6 4%
Swelling >30 mm	3 1%	0 0%	0 0%

68. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Description	Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm
Time Frame	Within 8 days (Day 0-7) after fourth dose vaccination

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
Measure Participants	232	126	130
Any limb circumference	61 21.3%	46 14.4%	36 24%
Limb circumference >20 mm	2 0.7%	5 1.6%	5 3.3%
Limb circumference >40 mm	0 0%	0 0%	0 0%
Any pain	79 27.5%	42 13.2%	48 32%
Grade 2 or 3 pain	26 9.1%	15 4.7%	12 8%
Grade 3 pain	3 1%	2 0.6%	3 2%
Any redness	81 28.2%	40 12.5%	39 26%
Redness >10 mm	12 4.2%	10 3.1%	11 7.3%
Redness >30 mm	4 1.4%	3 0.9%	4 2.7%
Any swelling	49 17.1%	19 6%	20 13.3%
Swelling > 10 mm	9 3.1%	1 0.3%	6 4%
Swelling > 30 mm	3 1%	0 0%	0 0%

69. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Description	Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C
Time Frame	Within 4 days (Day 0-3) after fourth dose vaccination

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	232	126	130
Any drowsinnes	72 25.1%	48 15%	41 27.3%
Grade 2 or 3 drowsiness	21 7.3%	7 2.2%	7 4.7%
Grade 3 drowsiness	2 0.7%	1 0.3%	1 0.7%
Fever ≥ 38.0°C	40 13.9%	19 6%	14 9.3%
Fever > 39.0°C	4 1.4%	1 0.3%	5 3.3%
Fever > 40.0°C	1 0.3%	0 0%	0 0%
Any irratibility	114 39.7%	65 20.4%	58 38.7%
Grade 2 or 3 irritability	42 14.6%	25 7.8%	23 15.3%
Grade 3 irritability	10 3.5%	0 0%	4 2.7%
Any loss of appetite	46 16%	34 10.7%	30 20%
Grade 2 or 3 loss of appetite	10 3.5%	1 0.3%	4 2.7%
Grade 3 loss of appetite	1 0.3%	0 0%	0 0%

70. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Description	Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C
Time Frame	Within 8 days (Day 0-7) after fourth dose vaccination

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	232	126	131
Any drowsiness	79 27.5%	48 15%	43 28.7%
Grade 2 or 3 drowsiness	27 9.4%	8 2.5%	8 5.3%
Grade 3 drowsiness	3 1%	1 0.3%	1 0.7%
Fever ≥ 38.0°C	54 18.8%	24 7.5%	19 12.7%
Fever > 39.0°C	9 3.1%	2 0.6%	9 6%
Fever > 40.0°C	3 1%	0 0%	2 1.3%
Any irritability	125 43.6%	67 21%	62 41.3%
Grade 2 or 3 irritability	51 17.8%	27 8.5%	28 18.7%
Grade 3 irritability	13 4.5%	1 0.3%	4 2.7%
Any loss of appetite	56 19.5%	35 11%	33 22%
Grade 2 or 3 loss of appetite	13 4.5%	1 0.3%	4 2.7%
Grade 3 loss of appetite	2 0.7%	0 0%	0 0%

71. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame	During the 31-day follow-up period following the fourth dose

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	236	130	132
Count of Participants [Participants]	102 35.5%	39 12.2%	58 38.7%

72. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame	During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	236	130	132
Count of Participants [Participants]	6 2.1%	2 0.6%	3 2%

73. Secondary Outcome

Title	Number of Subjects Reporting New Onset of Chronic Illness(es)
Description	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame	From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	236	130	132
Count of Participants [Participants]	2 0.7%	1 0.3%	0 0%

74. Secondary Outcome

Title	Number of Subjects Reporting Rash
Description	An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.
Time Frame	From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	236	130	132
Count of Participants [Participants]	10 3.5%	10 3.1%	10 6.7%

75. Secondary Outcome

Title	Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses
Description	Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Time Frame	From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	236	130	132
ER visit	6 2.1%	1 0.3%	7 4.7%
Physician's office visit	75 26.1%	31 9.7%	43 28.7%
Physician's o. visit not related to common illness	13 4.5%	8 2.5%	13 8.7%

76. Secondary Outcome

Title	Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)
Description	Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).
Time Frame	Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose

Outcome Measure Data

Analysis Population Description

The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.

Arm/Group Title	MenHibrix Group	ActHIB/ActHIB Group	ActHIB/MenHibrix Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.	Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
Measure Participants	232	126	130
[within Day 0-3 following the fourth dose]	3 1%	0 0%	0 0%
[within Day 0-7 following the fourth dose]	3 1%	0 0%	0 0%

Adverse Events

Time Frame	Solicited symptoms: Within 4 or 8 days after vaccination. Unsolicited AEs: Within 31 days (Days 0-30) after vaccination. SAEs: Throughout the entire study period. Depending on groups, periods may be split into subperiods (cf below).
Adverse Event Reporting Description	Solicited AEs reports were not collected from Menomune Group. SAEs reporting was split: a) Day 0 to 6 months post-Dose 3 (Primary Phase groups); and b) within 31 days of 4th Dose and c) from Day 31 post 4th Dose up to 6 months afterwards (4th Dose Phase groups). N at risk for Menomune Group = N at risk for AEs occurring in at least 5% of subjects
Arm/Group Title	MenHibrix Group		ActHIB Group		Menomune Group		ActHIB/MenHibrix Group		ActHIB/ActHIB Group
Arm/Group Description	Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.		During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.		Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.		Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.		Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
All Cause Mortality
	MenHibrix Group		ActHIB Group		Menomune Group		ActHIB/MenHibrix Group		ActHIB/ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	MenHibrix Group		ActHIB Group		Menomune Group		ActHIB/MenHibrix Group		ActHIB/ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/287 (5.6%)		20/319 (6.3%)		0/150 (0%)		1/132 (0.8%)		2/130 (1.5%)
Congenital, familial and genetic disorders
Tuberous sclerosis	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Gastrointestinal disorders
Gastro esophageal reflux disease	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Intussusception	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
General disorders
Sudden infant death syndrome	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Death	1/236 (0.4%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		0/130 (0%)
Infections and infestations
Bronchiolitis	4/287 (1.4%)		5/319 (1.6%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Otitis media	3/287 (1%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Viral infection	1/287 (0.3%)		2/319 (0.6%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Croup infectious	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Erythema infectiosum	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Gastroenteritis	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Influenza	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Pneumonia respiratory syncytial viral	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Respiratory syncytial virus infection	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Respiratory tract infection	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Streptococcal bacteremia	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Bronchiolitis	1/236 (0.4%)		0/0 (NaN)		0/0 (NaN)		1/132 (0.8%)		0/130 (0%)
Abscess limb	0/236 (0%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		1/130 (0.8%)
Cellulitis	0/236 (0%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		1/130 (0.8%)
Sepsis	0/236 (0%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		1/130 (0.8%)
Gastroenteritis	3/236 (1.3%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		1/130 (0.8%)
Respiratory syncytial virus infection	0/236 (0%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		1/130 (0.8%)
Injury, poisoning and procedural complications
Burns first degree	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Burns second degree	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Thermal burn	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Metabolism and nutrition disorders
Dehydration	3/287 (1%)		6/319 (1.9%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Failure to thrive	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Hyperkalemia	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Dehydration	2/236 (0.8%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		0/130 (0%)
Hypoglycemia	0/236 (0%)		0/0 (NaN)		0/0 (NaN)		1/132 (0.8%)		0/130 (0%)
Hypokalemia	1/236 (0.4%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		0/130 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retinoblastoma bilateral	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Nervous system disorders
Arachnoid cyst	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Dyskinesia	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Infantile spasms	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Febrile convulsion	1/236 (0.4%)		0/0 (NaN)		0/0 (NaN)		0/132 (0%)		0/130 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchial hyper reactivity	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Hypoxia	0/287 (0%)		1/319 (0.3%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Respiratory distress	1/287 (0.3%)		0/319 (0%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Wheezing	0/236 (0%)		0/0 (NaN)		0/0 (NaN)		1/132 (0.8%)		0/130 (0%)
Other (Not Including Serious) Adverse Events
	MenHibrix Group		ActHIB Group		Menomune Group		ActHIB/MenHibrix Group		ActHIB/ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	263/287 (91.6%)		302/319 (94.7%)		18/150 (12%)		62/132 (47%)		67/130 (51.5%)
Eye disorders
Conjunctivitis	11/287 (3.8%)		21/319 (6.6%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Gastrointestinal disorders
Diarrhea	15/287 (5.2%)		16/319 (5%)		1/150 (0.7%)		0/0 (NaN)		0/0 (NaN)
Flatulence	16/287 (5.6%)		7/319 (2.2%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Teething	19/236 (8.1%)		0/0 (NaN)		0/0 (NaN)		5/132 (3.8%)		3/130 (2.3%)
General disorders
Pain	129/286 (45.1%)		171/317 (53.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Redness	112/286 (39.2%)		148/317 (46.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Swelling	90/286 (31.5%)		110/317 (34.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Pain	129/286 (45.1%)		171/317 (53.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Redness	113/286 (39.5%)		148/317 (46.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Swelling	90/286 (31.5%)		111/317 (35%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Drowsiness	185/286 (64.7%)		224/317 (70.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever	110/286 (38.5%)		150/317 (47.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	217/286 (75.9%)		268/317 (84.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Loss of appetite	123/286 (43%)		159/317 (50.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Drowsiness	187/286 (65.4%)		227/317 (71.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever	115/286 (40.2%)		158/317 (49.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	222/286 (77.6%)		272/317 (85.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Loss of appetite	127/286 (44.4%)		164/317 (51.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Limb circumference	59/232 (25.4%)		0/0 (NaN)		0/0 (NaN)		36/130 (27.7%)		44/126 (34.9%)
Pain	79/232 (34.1%)		0/0 (NaN)		0/0 (NaN)		48/130 (36.9%)		42/126 (33.3%)
Redness	81/232 (34.9%)		0/0 (NaN)		0/0 (NaN)		38/130 (29.2%)		40/126 (31.7%)
Swelling	49/232 (21.1%)		0/0 (NaN)		0/0 (NaN)		20/130 (15.4%)		19/126 (15.1%)
Drowsiness	72/232 (31%)		0/0 (NaN)		0/0 (NaN)		41/131 (31.3%)		48/126 (38.1%)
Fever	40/232 (17.2%)		0/0 (NaN)		0/0 (NaN)		14/131 (10.7%)		19/126 (15.1%)
Irritability	114/232 (49.1%)		0/0 (NaN)		0/0 (NaN)		58/131 (44.3%)		65/126 (51.6%)
Loss of appetite	46/232 (19.8%)		0/0 (NaN)		0/0 (NaN)		30/131 (22.9%)		34/126 (27%)
Limb circumference	61/232 (26.3%)		0/0 (NaN)		0/0 (NaN)		36/130 (27.7%)		46/126 (36.5%)
Pain	79/232 (34.1%)		0/0 (NaN)		0/0 (NaN)		48/130 (36.9%)		42/126 (33.3%)
Redness	81/232 (34.9%)		0/0 (NaN)		0/0 (NaN)		39/130 (30%)		40/126 (31.7%)
Swelling	49/232 (21.1%)		0/0 (NaN)		0/0 (NaN)		20/130 (15.4%)		19/126 (15.1%)
Drowsiness	79/232 (34.1%)		0/0 (NaN)		0/0 (NaN)		43/131 (32.8%)		48/126 (38.1%)
Fever	54/232 (23.3%)		0/0 (NaN)		0/0 (NaN)		19/131 (14.5%)		24/126 (19%)
Irritability	125/232 (53.9%)		0/0 (NaN)		0/0 (NaN)		62/131 (47.3%)		67/126 (53.2%)
Loss of appetite	56/232 (24.1%)		0/0 (NaN)		0/0 (NaN)		33/131 (25.2%)		35/126 (27.8%)
Infections and infestations
Upper respiratory tract infection	77/287 (26.8%)		71/319 (22.3%)		4/150 (2.7%)		0/0 (NaN)		0/0 (NaN)
Otitis media	67/287 (23.3%)		55/319 (17.2%)		6/150 (4%)		0/0 (NaN)		0/0 (NaN)
Bronchiolitis	21/287 (7.3%)		25/319 (7.8%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)
Viral infection	15/287 (5.2%)		21/319 (6.6%)		2/150 (1.3%)		0/0 (NaN)		0/0 (NaN)
Otitis media	26/236 (11%)		0/0 (NaN)		0/0 (NaN)		12/132 (9.1%)		11/130 (8.5%)
Upper respiratory tract infection	22/236 (9.3%)		0/0 (NaN)		0/0 (NaN)		5/132 (3.8%)		10/130 (7.7%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	29/287 (10.1%)		18/319 (5.6%)		3/150 (2%)		0/0 (NaN)		0/0 (NaN)
Cough	11/287 (3.8%)		18/319 (5.6%)		4/150 (2.7%)		0/0 (NaN)		0/0 (NaN)
Skin and subcutaneous tissue disorders
Eczema	13/287 (4.5%)		23/319 (7.2%)		0/150 (0%)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.