Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00127855
• Collaborator: (none)
• Enrollment: 409
• Locations: 3
• Arms: 5
• Duration (Months): 11.4
• Patients Per Site: 136.3
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief Summary

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.

Condition or Disease	Intervention/Treatment	Phase
Haemophilus Influenzae Type b; Neisseria Meningitidis	Biological: Hib-MenCY-TT vaccine (MenHibrix); Biological: Meningitec®; Biological: ActHIB®; Biological: Infanrix® Penta; Biological: Prevenar®; Biological: Mencevax® ACWY; Biological: PRP (Polyribosyl Ribitol Phosphate)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 409 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Feb 1, 2004
• Actual Study Completion Date: Feb 12, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MenHibrix Formulation 1 Group Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: Hib-MenCY-TT vaccine (MenHibrix); Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively; Biological: Infanrix® Penta; Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.; Other Names: DTPa-HBV-IPV vaccine ; Biological: Prevenar®; Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.; Biological: Mencevax® ACWY; One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.; Biological: PRP (Polyribosyl Ribitol Phosphate); One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Experimental: MenHibrix Formulation 2 Group Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: Hib-MenCY-TT vaccine (MenHibrix); Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively; Biological: Infanrix® Penta; Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.; Other Names: DTPa-HBV-IPV vaccine ; Biological: Prevenar®; Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.; Biological: Mencevax® ACWY; One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.; Biological: PRP (Polyribosyl Ribitol Phosphate); One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Experimental: MenHibrix Formulation 3 Group Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: Hib-MenCY-TT vaccine (MenHibrix); Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively; Biological: Infanrix® Penta; Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.; Other Names: DTPa-HBV-IPV vaccine ; Biological: Prevenar®; Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.; Biological: Mencevax® ACWY; One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.; Biological: PRP (Polyribosyl Ribitol Phosphate); One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Active Comparator: Menjugate Group Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: Meningitec®; Three doses were administered IM in right lower thigh at Months 0,2 and 4.; Biological: ActHIB®; Three doses were administered IM in left thigh at Months 0,2 and 4.; Biological: Infanrix® Penta; Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.; Other Names: DTPa-HBV-IPV vaccine ; Biological: Mencevax® ACWY; One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.; Biological: PRP (Polyribosyl Ribitol Phosphate); One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Active Comparator: ActHIB Group Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: ActHIB®; Three doses were administered IM in left thigh at Months 0,2 and 4.; Biological: Infanrix® Penta; Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.; Other Names: DTPa-HBV-IPV vaccine ; Biological: Prevenar®; Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.; Biological: Mencevax® ACWY; One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.; Biological: PRP (Polyribosyl Ribitol Phosphate); One dose was administered IM in deltoid region of left arm at Month 10 as booster.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter [One month after primary vaccination (Month 5)]

   The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).

2. Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8 [One month after primary vaccination (Month 5)]

   The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

3. Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8 [One month after primary vaccination (Month 5)]

   The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Secondary Outcome Measures

1. Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8 [Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

2. Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

3. Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8 [Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

4. Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

5. Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL) [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

6. Anti-polysaccharide C (PSC) Antibody Concentration [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

7. Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL) [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

8. Anti-polysaccharide Y (PSY) Antibody Concentration [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

9. Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

   The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.

10. Anti-PRP Antibody Concentration [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)]

    Concentrations are presented as GMCs and expressed as µg/mL.

11. Number of Subjects Seroprotected for Anti-diphtheria Antibodies [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

12. Anti-diphtheria Antibody Concentrations [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

13. Number of Subjects Seroprotected for Anti-tetanus Antibodies [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

14. Anti-tetanus Antibody Concentrations [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

15. Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

16. Anti- FHA Antibody Concentrations [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

17. Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

18. Anti-PRN Antibody Concentrations [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

19. Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

20. Anti- PT Antibody Concentrations [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

21. Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).

22. Anti- HBs Antibody Concentrations [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).

23. Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.

24. Anti-poliovirus Types 1, 2 and 3 Antibody Titers [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.

25. Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).

26. Anti-pneumococcal Antibody Concentrations [Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)]

    Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).

27. Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course [During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course]

    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

28. Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose [During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose]

    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

29. Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course [During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course]

    Unsolicited adverse event covers any adverse event 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.

30. Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose [During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose]

    Unsolicited adverse event covers any adverse event 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.

31. Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course [Up to one month after the 3-dose primary vaccination course (Month 5)]

    Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

32. Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose [Up to one month following administration of the polysaccharide challenge dose (Month 11)]

    Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 12 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• A male or female between, and including, 6 and 12 weeks (42-90 days) 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 into the study.

• Vaccinated against hepatitis B at birth.

• Born after a gestation period of 36 - 42 weeks.

Exclusion criteria:

• Use of any investigational or non-registered 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 of immunosuppressants or other immune-modifying drugs since birth

• Any chronic drug therapy to be continued during the study period.

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

• Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.

• History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

• A family history of congenital or hereditary immunodeficiency.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

• Major congenital defects or serious chronic illness.

• History of any neurologic disorders or seizures.

• Acute disease at the time of enrolment.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	North Adelaide	South Australia	Australia	5006
2	GSK Investigational Site	Carlton	Victoria	Australia	3053
3	GSK Investigational Site	Subiaco	Western Australia	Australia	6018

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.
• Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. Epub 2007 Oct 25.
• T Nolan et al. A novel Haemophilus influenzae type b - meningococcal serogroups C and Y conjugate (Hib-MenCY-TT) vaccine induces persistent immune responses and immune memory. Abstract presented at Pediatric Academic Societies' (PAS) Annual meeting. San Francisco, California, US, 29 April to 2 May 2006.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00127855
• Other Study ID Numbers: 792014/001; 792014/002
• First Posted: Aug 9, 2005
• Last Update Posted: Aug 27, 2018
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Invasive bacterial disease caused by Hib; Neisseria meningitidis serogroups C & Y
• Additional relevant MeSH terms: Influenza, Human; Haemophilus Infections; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Pre-assignment Detail	Of the 409 subjects enrolled, two subjects were determined to be ineligible for enrolment and were actually never vaccinated. Not all subjects that started the primary vaccination course returned for the polysaccharide challenge dose administration.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Period Title: Primary Vaccination Course
STARTED	82	82	80	81	82
COMPLETED	80	81	78	81	78
NOT COMPLETED	2	1	2	0	4
Period Title: Primary Vaccination Course
STARTED	80	79	77	81	77
COMPLETED	80	79	77	81	77
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group	Total
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Total of all reporting groups
Overall Participants	82	82	80	81	82	407
Age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	8.1 (1.39)	8.3 (1.46)	8.2 (1.65)	8.0 (1.65)	8.1 (1.43)	8.1 (1.50)
Sex: Female, Male (Count of Participants)
Female	38 46.3%	45 54.9%	41 51.3%	43 53.1%	37 45.1%	204 50.1%
Male	44 53.7%	37 45.1%	39 48.8%	38 46.9%	45 54.9%	203 49.9%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter
Description	The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
Time Frame	One month after primary vaccination (Month 5)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	74	76	70	74	74
Number [Subjects]	72	75	65	66	70

2. Primary Outcome

Title	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
Description	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Time Frame	One month after primary vaccination (Month 5)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	69	76	72	74	76
Number [Subjects]	69	76	72	74	1

3. Primary Outcome

Title	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8
Description	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Time Frame	One month after primary vaccination (Month 5)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	67	68	69	68	74
Number [Subjects]	66	68	68	10	12

4. Secondary Outcome

Title	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
Description	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Time Frame	Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	69	73	73	79	70
Day 0 (N= 68; 66; 63; 66; 70)	2	6	2	3	1
Month 10 (N= 69; 71; 73; 74; 68)	67	70	70	67	6
Month 11 (N= 69; 73; 71; 79; 66)	69	73	71	77	18

5. Secondary Outcome

Title	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers
Description	Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	69	76	73	79	76
Day 0 (N= 68; 66; 63; 66; 70)	4.3	5.2	4.2	4.2	4.1
Month 5 (N= 69; 76; 72; 74; 76)	1293.1	1065.6	968.4	1931.9	4.2
Month 10 (N= 69; 71; 73; 74; 68)	260.5	214.2	199.8	170.8	4.9
Month 11 (N= 69; 73; 71; 79; 66)	1985.5	919.5	1530.4	774.8	9.0

6. Secondary Outcome

Title	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8
Description	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Time Frame	Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	69	71	70	77	71
Day 0 (N= 68; 65; 58; 63; 66)	4	7	5	9	4
Month 10 (N= 69; 69; 70; 71; 68)	61	55	60	17	22
Month 11 (N= 68; 71; 70; 77; 71)	68	71	69	32	38

7. Secondary Outcome

Title	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers
Description	Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	69	71	70	77	74
Day 0 (N= 68; 65; 58; 63; 66)	4.6	5.6	5.1	6.3	4.9
Month 5 (N= 67; 68; 69; 68; 74)	843.5	1020.0	741.8	6.9	7.3
Month 10 (N= 69; 69; 70; 71; 68)	114.5	139.6	129.9	10.0	13.4
Month 11 (N= 68; 71; 70; 77; 71)	1838.0	1539.8	1653.8	18.8	32.0

8. Secondary Outcome

Title	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Description	The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	71	70	71	76	71
Day 0 (N= 54; 54; 49; 56; 56)	5	5	6	5	4
Month 5 (N= 63; 65; 61; 62; 63)	63	65	61	62	1
Month 10 (N= 63; 68; 61; 74; 67)	63	68	61	74	1
Month 11 (N= 71; 70; 71; 76; 71)	71	70	71	76	69

9. Secondary Outcome

Title	Anti-polysaccharide C (PSC) Antibody Concentration
Description	Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	71	70	71	76	71
Day 0 (N= 54; 54; 49; 56; 56)	0.17	0.17	0.17	0.17	0.17
Month 5 (N= 63; 65; 61; 62; 63)	12.02	12.09	9.95	15.36	0.15
Month 10 (N= 63; 68; 61; 74; 67)	3.11	3.10	2.74	2.87	0.15
Month 11 (N= 71; 70; 71; 76; 71)	11.47	7.94	10.96	7.56	1.49

10. Secondary Outcome

Title	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Description	The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	70	71	72	77	71
Day 0 (N= 51; 51; 47; 56; 54)	3	4	3	7	7
Month 5 (N= 67; 70; 72; 66; 69)	67	70	72	2	0
Month 10 (N= 70; 69; 71; 76; 67)	70	69	70	0	1
Month 11 (N= 69; 71; 71; 77; 71)	69	71	71	70	64

11. Secondary Outcome

Title	Anti-polysaccharide Y (PSY) Antibody Concentration
Description	Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	70	71	72	77	71
Day 0 (N= 51; 51; 47; 56; 54)	0.17	0.18	0.17	0.20	0.19
Month 5 (N= 67; 70; 72; 66; 69)	19.22	19.09	15.83	0.16	0.15
Month 10 (N= 70; 69; 71; 76; 67)	5.26	5.20	4.10	0.15	0.15
Month 11 (N= 69; 71; 71; 77; 71)	47.95	37.15	51.12	1.37	1.33

12. Secondary Outcome

Title	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Description	The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	74	76	73	79	74
Day 0 ≥ 0.15 µg/mL (N= 68; 70; 67; 67; 73)	29	37	41	32	37
Month 5 ≥ 0.15 µg/mL (N= 74; 76; 70; 74; 74)	74	76	70	73	74
Month 10 ≥ 0.15 µg/mL (N= 70; 72; 73; 76; 70)	70	71	72	71	68
Month 11 ≥ 0.15 µg/mL (N= 68; 73; 71; 79; 72)	68	72	71	78	71
Day 0 ≥ 1 µg/mL (N= 68; 70; 67; 67; 73)	7	10	6	6	8
Month 5 ≥ 1 µg/mL (N= 74; 76; 70; 74; 74)	72	75	65	66	70
Month 10 ≥ 1 µg/mL (N= 70; 72; 73; 76; 70)	46	42	36	39	41
Month 11 ≥ 1 µg/mL (N= 68; 73; 71; 79; 72)	67	69	65	57	58

13. Secondary Outcome

Title	Anti-PRP Antibody Concentration
Description	Concentrations are presented as GMCs and expressed as µg/mL.
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	74	76	73	79	74
Day 0 (N= 68; 70; 67; 67; 73)	0.152	0.224	0.214	0.172	0.201
Month 5 (N= 74; 76; 70; 74; 74)	6.441	7.324	5.577	4.465	5.714
Month 10 (N= 70; 72; 73; 76; 70)	1.386	1.383	1.148	0.949	1.141
Month 11 (N= 68; 73; 71; 79; 72)	8.653	6.750	5.112	2.512	3.283

14. Secondary Outcome

Title	Number of Subjects Seroprotected for Anti-diphtheria Antibodies
Description	Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	78	78	75	80	76
Day 0 (N= 68; 70; 65; 69; 74)	26	28	28	26	29
Month 5 (N= 74; 76; 74; 77; 76)	74	76	74	77	76
Month 10 (N= 78; 78; 75; 80; 75)	76	75	72	74	75

15. Secondary Outcome

Title	Anti-diphtheria Antibody Concentrations
Description	Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	78	78	75	80	76
Day 0 (N= 68; 70; 65; 69; 74)	0.090	0.098	0.101	0.090	0.093
Month 5 (N= 74; 76; 74; 77; 76)	1.721	1.797	2.000	1.845	1.970
Month 10 (N= 78; 78; 75; 80; 75)	0.513	0.505	0.519	0.405	0.543

16. Secondary Outcome

Title	Number of Subjects Seroprotected for Anti-tetanus Antibodies
Description	Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	78	78	75	80	76
Day 0 (N= 62; 64; 60; 60; 68)	54	58	57	57	62
Month 5 (N= 74; 76; 74; 77; 76)	74	76	74	77	76
Month 10 (N= 78; 78; 75; 80; 75)	78	78	74	78	75

17. Secondary Outcome

Title	Anti-tetanus Antibody Concentrations
Description	Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	78	78	75	80	76
Day 0 (N= 62; 64; 60; 60; 68)	0.460	0.470	0.501	0.562	0.533
Month 5 (N= 74; 76; 74; 77; 76)	3.301	3.816	3.366	1.877	2.033
Month 10 (N= 78; 78; 75; 80; 75)	1.114	1.307	1.062	0.603	0.756

18. Secondary Outcome

Title	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies
Description	Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	78	78	75	79	76
Day 0 (N= 64; 69; 65; 67; 70)	34	28	38	44	31
Month 5 (N= 74; 76; 74; 77; 76)	74	76	74	77	76
Month 10 (N= 78; 78; 75; 79; 75)	77	77	72	79	75

19. Secondary Outcome

Title	Anti- FHA Antibody Concentrations
Description	Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	77	77	74	79	76
Day 0 (N= 64; 69; 65; 67; 70)	5.1	4.6	5.8	7.4	4.8
Month 5 (N= 74; 76; 74; 77; 76)	137.2	141.5	136.2	132.1	146.7
Month 10 (N= 78; 78; 75; 79; 75)	49.4	50.9	44.3	39.9	50.2

20. Secondary Outcome

Title	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies
Description	Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	78	78	75	80	76
Day 0 (N= 67; 63; 67; 68; 71)	20	26	25	30	26
Month 5 (N= 74; 76; 74; 77; 76)	74	76	74	76	76
Month 10 (N= 78; 78; 75; 80; 75)	76	75	71	73	74

21. Secondary Outcome

Title	Anti-PRN Antibody Concentrations
Description	Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	78	78	75	80	76
Day 0 (N= 67; 63; 67; 68; 71)	3.9	4.7	4.6	5.3	4.4
Month 5 (N= 74; 76; 74; 77; 76)	128.3	120.7	106.2	112.9	137.8
Month 10 (N= 78; 78; 75; 80; 75)	36.2	31.8	27.3	27.2	35.8

22. Secondary Outcome

Title	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies
Description	Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	77	76	74	78	76
Day 0 (N= 65; 66; 65; 63; 74)	5	6	5	11	3
Month 5 (N= 74; 76; 74; 77; 76)	74	76	74	77	76
Month 10 (N= 77; 76; 73; 78; 75)	71	66	62	61	63

23. Secondary Outcome

Title	Anti- PT Antibody Concentrations
Description	Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	77	76	74	78	76
Day 0 (N= 65; 66; 65; 63; 74)	2.7	2.7	2.8	3.1	2.7
Month 5 (N= 74; 76; 74; 77; 76)	55.1	55.2	53.7	49.7	54.8
Month 10 (N= 77; 76; 73; 78; 75)	11.6	11.6	9.9	8.2	9.8

24. Secondary Outcome

Title	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies
Description	Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	74	74	74	76	75
Day 0 (N= 57; 55; 56; 52; 57)	15	16	12	14	22
Month 5 (N= 72; 74; 74; 76; 75)	71	74	74	76	74
Month 10 (N= 74; 70; 70; 75; 69)	72	68	68	72	68

25. Secondary Outcome

Title	Anti- HBs Antibody Concentrations
Description	Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	74	74	74	76	75
Day 0 (N= 57; 55; 56; 52; 57)	13.7	12.2	10.0	10.1	18.8
Month 5 (N= 72; 74; 74; 76; 75)	1769.2	1840.7	1652.6	1752.2	1609.7
Month 10 (N= 74; 70; 70; 75; 69)	452.3	490.5	452.9	390.5	534.9

26. Secondary Outcome

Title	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Description	Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	71	70	70	76	67
Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	45	50	44	49	45
Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	62	68	66	66	65
Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	70	65	69	76	65
Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	42	40	36	44	43
Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	59	66	64	66	63
Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	70	66	65	71	64
Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	20	20	24	22	21
Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	62	68	65	65	65
Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	71	69	67	75	65

27. Secondary Outcome

Title	Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Description	Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	71	70	70	76	67
Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	36.7	33.3	32.9	52.3	36.6
Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	669.6	476.8	574.7	454.0	517.6
Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	175.8	120.6	162.4	116.4	166.4
Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	14.9	13.8	15.9	17.2	17.1
Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	533.8	369.8	408.0	348.9	368.0
Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	139.8	94.1	110.1	89.6	88.3
Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	6.4	6.6	7.9	7.7	8.0
Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	1266.3	1034.8	1062.2	1084.9	945.5
Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	348.4	263.8	250.9	264.0	203.9

28. Secondary Outcome

Title	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Description	Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	73	71	72	77	67
Anti-4 ≥ 0.05 µg/mL Day 0 (N=44;43;39;51;46)	10	9	10	11	10
Anti-4 ≥ 0.05 µg/mL Month 5 (N=69;70;69;58;66)	69	70	69	2	66
Anti-4 ≥ 0.05 µg/mL Month 10 (N=70;68;66;69;64)	70	68	65	1	64
Anti-6B ≥ 0.05 µg/mL Day 0 (N=44;41;39;49;49)	18	21	20	25	23
Anti-6B ≥ 0.05 µg/mL Month 5 (N=68;70;69;63;65)	65	69	61	3	60
Anti-6B ≥ 0.05 µg/mL Month 10 (N=69;63;62;71;62)	62	57	55	2	55
Anti-9V ≥ 0.05 µg/mL Day 0 (N=46;42;40;52;48)	19	22	23	23	18
Anti-9V ≥ 0.05 µg/mL Month 5 (N=68;71;71;62;67)	68	70	71	3	66
Anti-9V ≥ 0.05 µg/mL Month 10 (N=60;60;56;63;56)	60	58	56	5	56
Anti-14 ≥ 0.05 µg/mL Day 0 (N=31;33;31;41;43)	29	25	26	37	39
Anti-14 ≥ 0.05 µg/mL Month 5 (N=65;65;68;49;65)	65	65	68	24	65
Anti-14 ≥ 0.05 µg/mL Month 10 (N=68;67;64;69;61)	67	67	63	13	61
Anti-18C ≥ 0.05 µg/mL Day 0 (N=40;40;37;47;47)	20	19	21	23	25
Anti-18C ≥ 0.05 µg/mL Month 5 (N=67;71;72;65;67)	66	71	72	5	66
Anti-18C ≥ 0.05 µg/mL Month 10 (N=48;52;51;53;46)	47	52	51	0	45
Anti-19F ≥ 0.05 µg/mL Day 0 (N=42;42;36;50;45))	28	28	25	37	28
Anti-19F ≥ 0.05 µg/mL Month 5 (N=65;67;66;56;65)	65	66	66	7	65
Anti-19F ≥ 0.05 µg/mL Month 10 (N=73;71;65;77;63)	73	68	65	14	61
Anti-23F ≥ 0.05 µg/mL Day 0 (N=41;43;38;48;48)	17	14	15	19	22
Anti-23F ≥ 0.05 µg/mL Month 5 (N=66;68;70;59;66)	65	66	67	3	63
Anti-23F ≥ 0.05 µg/mL Month 10 (N=73;69;63;75;65)	71	67	59	0	63
Anti-4 ≥ 0.2 µg/mL Day 0 (N=44;43;39;51;46)	3	1	3	1	2
Anti-4 ≥ 0.2 µg/mL Month 5 (N=69;70;69;58;66)	69	70	69	1	66
Anti-4 ≥ 0.2 µg/mL Month 10 (N=70;68;66;69;64)	65	60	61	1	53
Anti-6B ≥ 0.2 µg/mL Day 0 (N=44;41;39;49;49)	6	11	7	9	8
Anti-6B ≥ 0.2 µg/mL Month 5 (N=68;70;69;63;65)	58	64	56	1	56
Anti-6B ≥ 0.2 µg/mL Month 10 (N=69;63;62;71;62)	45	41	49	0	42
Anti-9V ≥ 0.2 µg/mL Day 0 (N=46;42;40;52;48)	9	6	8	10	8
Anti-9V ≥ 0.2 µg/mL Month 5 (N=68;71;71;62;67)	68	69	71	1	66
Anti-9V ≥ 0.2 µg/mL Month 10 (N=60;60;56;63;56)	55	54	55	2	56
Anti-14 ≥ 0.2 µg/mL Day 0 (N=31;33;31;41;43)	20	18	16	28	30
Anti-14 ≥ 0.2 µg/mL Month 5 (N=65;65;68;49;65)	64	65	68	7	64
Anti-14 ≥ 0.2 µg/mL Month 10 (N=68;67;64;69;61)	64	65	63	5	60
Anti-18C ≥ 0.2 µg/mL Day 0 (N=40;40;37;47;47)	10	6	8	6	10
Anti-18C ≥ 0.2 µg/mL Month 5 (N=67;71;72;65;67)	66	70	72	2	65
Anti-18C ≥ 0.2 µg/mL Month 10 (N=48;52;51;53;46)	47	50	50	0	42
Anti-19F ≥ 0.2 µg/mL Day 0 (N=42;42;36;50;45)	14	18	16	22	15
Anti-19F ≥ 0.2 µg/mL Month 5 (N=65;67;66;56;65)	65	66	66	2	63
Anti-19F ≥ 0.2 µg/mL Month 10 (N=73;71;65;77;63)	54	51	55	8	45
Anti-23F ≥ 0.2 µg/mL Day 0 (N=41;43;38;48;48)	5	6	7	9	8
Anti-23F ≥ 0.2 µg/mL Month 5 (N=66;68;70;59;66)	64	64	67	0	62
Anti-23F ≥ 0.2 µg/mL Month 10 (N=73;69;63;75;65)	66	56	53	0	52

29. Secondary Outcome

Title	Anti-pneumococcal Antibody Concentrations
Description	Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).
Time Frame	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	73	71	72	77	67
Anti-4 Day 0 (N= 44; 43; 39; 51; 46)	0.036	0.035	0.040	0.034	0.036
Anti-4 Month 5 (N= 69; 70; 69; 58; 66)	2.101	2.049	2.023	0.027	2.062
Anti-4 Month 10 (N= 70; 68; 66; 69; 64)	0.495	0.528	0.508	0.026	0.450
Anti-6B Day 0 (N= 44; 41; 39; 49; 49)	0.055	0.080	0.067	0.070	0.067
Anti-6B Month 5 (N= 68; 70; 69; 63; 65)	1.060	1.079	0.834	0.027	0.879
Anti-6B Month 10 (N= 69; 63; 62; 71; 62)	0.307	0.307	0.292	0.026	0.308
Anti-9V Day 0 (N= 46; 42; 40; 52; 48)	0.058	0.065	0.079	0.059	0.055
Anti-9V Month 5 (N= 68; 71; 71; 62; 67)	3.102	2.363	2.823	0.028	2.651
Anti-9V Month 10 (N= 60; 60; 56; 63; 56)	0.818	0.721	0.933	0.030	0.881
Anti-14 Day 0 (N= 31; 33; 31; 41; 43)	0.367	0.227	0.258	0.394	0.388
Anti-14 Month 5 (N= 65; 65; 68; 49; 65)	4.095	5.592	4.309	0.062	4.372
Anti-14 Month 10 (N= 68; 67; 64; 69; 61)	2.362	2.767	2.549	0.039	2.379
Anti-18C Day 0 (N= 40; 40; 37; 47; 47)	0.073	0.063	0.075	0.063	0.078
Anti-18C Month 5 (N= 67; 71; 72; 65; 67)	3.518	2.969	2.936	0.029	3.326
Anti-18C Month 10 (N= 48; 52; 51; 53; 46)	0.775	0.742	0.708	0.025	0.668
Anti-19F Day 0 (N= 42; 42; 36; 50; 45)	0.124	0.126	0.129	0.135	0.115
Anti-19F Month 5 (N= 65; 67; 66; 56; 65)	2.303	1.846	2.061	0.030	1.881
Anti-19F Month 10 (N= 73; 71; 65; 77; 63)	0.413	0.335	0.397	0.042	0.339
Anti-23F Day 0 (N= 41; 43; 38; 48; 48)	0.053	0.045	0.062	0.060	0.065
Anti-23F Month 5 (N= 66; 68; 70; 59; 66)	2.581	2.112	2.098	0.027	1.988
Anti-23F Month 10 (N= 73; 69; 63; 75; 65)	0.783	0.642	0.644	0.025	0.578

30. Secondary Outcome

Title	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Description	Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
Time Frame	During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	81	82	79	81	82
Pain	54	50	53	66	60
Redness	67	67	64	75	69
Swelling	53	64	56	60	58
Drowsiness	65	72	58	70	67
Irritability	76	79	76	80	80
Loss of appetite	57	56	49	47	58
Fever	65	64	64	64	70

31. Secondary Outcome

Title	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Description	Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
Time Frame	During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	80	79	77	81	77
Pain	19	15	18	17	16
Redness	39	27	27	44	29
Swelling	15	15	13	15	12
Drowsiness	26	25	17	26	18
Irritability	48	48	45	46	49
Loss of appetite	26	27	25	24	23
Fever	29	20	27	36	34

32. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course
Description	Unsolicited adverse event covers any adverse event 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 (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	82	82	80	81	82
Number [Subjects]	64	68	56	58	68

33. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose
Description	Unsolicited adverse event covers any adverse event 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 (Day 0-30) follow-up period after administration of the polysaccharide challenge dose

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Booster Total Vaccinated Cohort.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	80	79	77	81	77
Number [Subjects]	39	46	47	50	52

34. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course
Description	Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame	Up to one month after the 3-dose primary vaccination course (Month 5)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	82	82	80	81	82
Number [Subjects]	5	5	2	4	6

35. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose
Description	Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame	Up to one month following administration of the polysaccharide challenge dose (Month 11)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Booster Total Vaccinated Cohort.

Arm/Group Title	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Measure Participants	80	79	77	81	77
Number [Subjects]	0	0	0	0	2

Adverse Events

Time Frame	SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
Adverse Event Reporting Description	The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
Arm/Group Title	MenHibrix Formulation 1 Group		MenHibrix Formulation 2 Group		MenHibrix Formulation 3 Group		Menjugate Group		ActHIB Group
Arm/Group Description	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.		Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.		Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.		Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.		Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
All Cause Mortality
	MenHibrix Formulation 1 Group		MenHibrix Formulation 2 Group		MenHibrix Formulation 3 Group		Menjugate Group		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 Formulation 1 Group		MenHibrix Formulation 2 Group		MenHibrix Formulation 3 Group		Menjugate Group		ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/82 (6.1%)		5/82 (6.1%)		2/80 (2.5%)		4/81 (4.9%)		6/82 (7.3%)
Cardiac disorders
Tachycardia	0/82 (0%)		0/82 (0%)		0/80 (0%)		1/81 (1.2%)		0/82 (0%)
Ear and labyrinth disorders
Deafness	0/82 (0%)		0/82 (0%)		0/80 (0%)		1/81 (1.2%)		0/82 (0%)
Gastrointestinal disorders
Haematemesis	0/82 (0%)		1/82 (1.2%)		0/80 (0%)		0/81 (0%)		0/82 (0%)
Immune system disorders
Milk allergy	0/82 (0%)		1/82 (1.2%)		0/80 (0%)		0/81 (0%)		0/82 (0%)
Infections and infestations
Bronchiolitis	1/82 (1.2%)		1/82 (1.2%)		1/80 (1.3%)		0/81 (0%)		4/82 (4.9%)
Croup infectious	0/82 (0%)		1/82 (1.2%)		0/80 (0%)		0/81 (0%)		0/82 (0%)
Escherichia urinary tract infection	0/82 (0%)		0/82 (0%)		0/80 (0%)		0/81 (0%)		1/82 (1.2%)
Gastroenteritis	1/82 (1.2%)		0/82 (0%)		0/80 (0%)		0/81 (0%)		0/82 (0%)
Gastroenteritis viral	2/82 (2.4%)		0/82 (0%)		0/80 (0%)		1/81 (1.2%)		0/82 (0%)
Influenza	0/82 (0%)		1/82 (1.2%)		0/80 (0%)		0/81 (0%)		0/82 (0%)
Lobar pneumonia	1/82 (1.2%)		0/82 (0%)		0/80 (0%)		0/81 (0%)		0/82 (0%)
Pneumonia	0/82 (0%)		1/82 (1.2%)		0/80 (0%)		1/81 (1.2%)		0/82 (0%)
Bronchiolitis	0/80 (0%)		0/79 (0%)		0/77 (0%)		0/81 (0%)		1/77 (1.3%)
Pneumonia	0/80 (0%)		0/79 (0%)		0/77 (0%)		0/81 (0%)		1/77 (1.3%)
Nervous system disorders
Convulsion	0/82 (0%)		0/82 (0%)		0/80 (0%)		1/81 (1.2%)		0/82 (0%)
Pregnancy, puerperium and perinatal conditions
Sudden infant death syndrome	0/82 (0%)		0/82 (0%)		1/80 (1.3%)		0/81 (0%)		0/82 (0%)
Reproductive system and breast disorders
Balanitis	0/82 (0%)		0/82 (0%)		0/80 (0%)		0/81 (0%)		1/82 (1.2%)
Other (Not Including Serious) Adverse Events
	MenHibrix Formulation 1 Group		MenHibrix Formulation 2 Group		MenHibrix Formulation 3 Group		Menjugate Group		ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/82 (98.8%)		81/82 (98.8%)		77/80 (96.3%)		81/81 (100%)		82/82 (100%)
Gastrointestinal disorders
Vomiting	6/82 (7.3%)		9/82 (11%)		7/80 (8.8%)		3/81 (3.7%)		9/82 (11%)
Diarrhoea	6/82 (7.3%)		10/82 (12.2%)		6/80 (7.5%)		7/81 (8.6%)		4/82 (4.9%)
Teething	7/82 (8.5%)		6/82 (7.3%)		3/80 (3.8%)		2/81 (2.5%)		7/82 (8.5%)
Gingival pain	1/82 (1.2%)		3/82 (3.7%)		3/80 (3.8%)		5/81 (6.2%)		2/82 (2.4%)
Teething	2/80 (2.5%)		5/79 (6.3%)		4/77 (5.2%)		6/81 (7.4%)		7/77 (9.1%)
Vomiting	4/80 (5%)		4/79 (5.1%)		3/77 (3.9%)		3/81 (3.7%)		5/77 (6.5%)
Diarrhea	4/80 (5%)		0/79 (0%)		2/77 (2.6%)		5/81 (6.2%)		0/77 (0%)
General disorders
Injection site bruising	12/82 (14.6%)		12/82 (14.6%)		15/80 (18.8%)		16/81 (19.8%)		11/82 (13.4%)
Pyrexia	7/82 (8.5%)		8/82 (9.8%)		3/80 (3.8%)		2/81 (2.5%)		8/82 (9.8%)
Injection site haemorrhage	7/80 (8.8%)		9/79 (11.4%)		3/77 (3.9%)		7/81 (8.6%)		7/77 (9.1%)
Pyrexia	2/80 (2.5%)		4/79 (5.1%)		10/77 (13%)		3/81 (3.7%)		6/77 (7.8%)
Pain at the injection site	54/81 (66.7%)		50/82 (61%)		53/79 (67.1%)		66/81 (81.5%)		60/82 (73.2%)
Redness at the injection site	67/81 (82.7%)		67/82 (81.7%)		64/79 (81%)		75/81 (92.6%)		69/82 (84.1%)
Swelling at the injection site	53/81 (65.4%)		64/82 (78%)		56/79 (70.9%)		60/81 (74.1%)		58/82 (70.7%)
Drowsiness	65/81 (80.2%)		72/82 (87.8%)		58/78 (74.4%)		70/81 (86.4%)		67/82 (81.7%)
Irritability	76/81 (93.8%)		79/82 (96.3%)		76/78 (97.4%)		80/81 (98.8%)		80/82 (97.6%)
Loss of appetite	57/81 (70.4%)		56/82 (68.3%)		49/78 (62.8%)		47/81 (58%)		58/82 (70.7%)
Fever	65/81 (80.2%)		64/82 (78%)		64/78 (82.1%)		64/81 (79%)		70/82 (85.4%)
Pain at the injection site	19/80 (23.8%)		15/79 (19%)		18/77 (23.4%)		17/81 (21%)		16/77 (20.8%)
Redness at the injection site	39/80 (48.8%)		27/79 (34.2%)		27/77 (35.1%)		44/81 (54.3%)		29/77 (37.7%)
Swelling at the injection site	15/80 (18.8%)		15/79 (19%)		13/77 (16.9%)		15/81 (18.5%)		12/77 (15.6%)
Drowsiness	26/80 (32.5%)		25/79 (31.6%)		17/77 (22.1%)		26/81 (32.1%)		18/77 (23.4%)
Irritability	48/80 (60%)		48/79 (60.8%)		45/77 (58.4%)		46/81 (56.8%)		49/77 (63.6%)
Loss of appetite	26/80 (32.5%)		27/79 (34.2%)		25/77 (32.5%)		24/81 (29.6%)		23/77 (29.9%)
Fever	29/80 (36.3%)		20/79 (25.3%)		27/77 (35.1%)		36/81 (44.4%)		34/77 (44.2%)
Infections and infestations
Upper respiratory tract infection	19/82 (23.2%)		24/82 (29.3%)		24/80 (30%)		25/81 (30.9%)		31/82 (37.8%)
Bronchiolitis	3/82 (3.7%)		4/82 (4.9%)		3/80 (3.8%)		0/81 (0%)		5/82 (6.1%)
Rhinitis	0/82 (0%)		3/82 (3.7%)		4/80 (5%)		3/81 (3.7%)		0/82 (0%)
Upper respiratory tract infection	12/80 (15%)		10/79 (12.7%)		14/77 (18.2%)		17/81 (21%)		11/77 (14.3%)
Otitis media	5/80 (6.3%)		3/79 (3.8%)		3/77 (3.9%)		1/81 (1.2%)		3/77 (3.9%)
Psychiatric disorders
Irritability	13/82 (15.9%)		6/82 (7.3%)		9/80 (11.3%)		5/81 (6.2%)		12/82 (14.6%)
Irritability	5/80 (6.3%)		6/79 (7.6%)		8/77 (10.4%)		6/81 (7.4%)		6/77 (7.8%)
Insomnia	0/80 (0%)		1/79 (1.3%)		1/77 (1.3%)		1/81 (1.2%)		4/77 (5.2%)
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	6/82 (7.3%)		9/82 (11%)		4/80 (5%)		10/81 (12.3%)		6/82 (7.3%)
Cough	4/82 (4.9%)		5/82 (6.1%)		4/80 (5%)		5/81 (6.2%)		4/82 (4.9%)
Rhinorhea	4/80 (5%)		6/79 (7.6%)		5/77 (6.5%)		7/81 (8.6%)		5/77 (6.5%)
Cough	2/80 (2.5%)		6/79 (7.6%)		3/77 (3.9%)		3/81 (3.7%)		3/77 (3.9%)
Nasal congestion	0/80 (0%)		1/79 (1.3%)		4/77 (5.2%)		0/81 (0%)		0/77 (0%)
Skin and subcutaneous tissue disorders
Rash	8/82 (9.8%)		2/82 (2.4%)		7/80 (8.8%)		3/81 (3.7%)		2/82 (2.4%)
Eczema	4/82 (4.9%)		6/82 (7.3%)		2/80 (2.5%)		0/81 (0%)		4/82 (4.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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.