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Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00344318
Collaborator
(none)
806
Enrollment
7
Locations
4
Arms
14.3
Actual Duration (Months)
115.1
Patients Per Site
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.

The study has 2 groups.

  • One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).

  • The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.

All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).

Condition or Disease Intervention/Treatment Phase
  • Biological: Pneumococcal conjugate vaccine GSK1024850A
  • Biological: Prevenar
  • Biological: Tritanrix-HepB
  • Biological: Hiberix
  • Biological: Polio Sabin.
  • Biological: Poliorix.
 Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
806 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age
Actual Study Start Date :
Aug 7, 2006
Actual Primary Completion Date :
Apr 27, 2007
Actual Study Completion Date :
Oct 17, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Synflorix 1 Group

Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.

Biological: Pneumococcal conjugate vaccine GSK1024850A
3 Intramuscular injections.

Biological: Tritanrix-HepB
3 Intramuscular injections
Other Names:
  • DTPw-HBV

    • Biological: Hiberix
    Reconstituted with Tritanrix before injection
    Other Names:
  • Hib

    • Biological: Polio Sabin.
    3 oral doses.
    Other Names:
  • OPV

    • Biological: Poliorix.
    3 intramuscular injections
    Other Names:
  • IPV

    		•
    Experimental: Synflorix 2 Group

    Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.

    Biological: Pneumococcal conjugate vaccine GSK1024850A
    3 Intramuscular injections.

    Biological: Tritanrix-HepB
    3 Intramuscular injections
    Other Names:
  • DTPw-HBV

    • Biological: Hiberix
    Reconstituted with Tritanrix before injection
    Other Names:
  • Hib

    • Biological: Polio Sabin.
    3 oral doses.
    Other Names:
  • OPV

    • Biological: Poliorix.
    3 intramuscular injections
    Other Names:
  • IPV

    		•
    Active Comparator: Prevenar 1 Group

    Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.

    Biological: Prevenar
    3 Intramuscular injections

    Biological: Tritanrix-HepB
    3 Intramuscular injections
    Other Names:
  • DTPw-HBV

    • Biological: Hiberix
    Reconstituted with Tritanrix before injection
    Other Names:
  • Hib

    • Biological: Polio Sabin.
    3 oral doses.
    Other Names:
  • OPV

    • Biological: Poliorix.
    3 intramuscular injections
    Other Names:
  • IPV

    		•
    Active Comparator: Prevenar 2 Group

    Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.

    Biological: Prevenar
    3 Intramuscular injections

    Biological: Tritanrix-HepB
    3 Intramuscular injections
    Other Names:
  • DTPw-HBV

    • Biological: Hiberix
    Reconstituted with Tritanrix before injection
    Other Names:
  • Hib

    • Biological: Polio Sabin.
    3 oral doses.
    Other Names:
  • OPV

    • Biological: Poliorix.
    3 intramuscular injections
    Other Names:
  • IPV

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) [Within 4 day (Days 0-3) after each dose and across doses]

      Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.

    Secondary Outcome Measures

    1. Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms [Within 4 day (Days 0-3) after each dose and across doses]

      Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

    2. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Within 4-day (Days 0-3) after each dose and across doses]

      Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.

    3. Number of Subjects With Unsolicited Adverse Events (AEs) [Within 31 days (Days 0-30) after each vaccination]

      An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

    4. Number of Subjects With Serious Adverse Events (SAEs) [During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group]

      Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    5. Number of Subjects With Serious Adverse (SAEs) [During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group]

      Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    6. Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

    7. Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.

    8. Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.

    9. Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8

    10. Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8.

    11. Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

    12. Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.

    13. Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8

    14. Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8

    15. Concentrations of Antibodies Against Protein D (Anti-PD) [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)

    16. Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) [One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™]

      Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.

    17. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects.

    18. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects.

    19. Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL

    20. Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects.

    21. Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL

    22. Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects.

    23. Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL

    24. Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Titers were expressed as geometric mean titres (GMTs).

    25. Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8

    26. Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination.

    27. Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL.

    28. Number of Subjects With Vaccine Response to Bordetella Pertussis [One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™]

      Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations < 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL).

    Eligibility Criteria

    Criteria

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

    • Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.

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

    • 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.

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

    Exclusion Criteria:

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

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

    • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.

    • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations

    • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.

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

    • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.

    • Acute disease at the time of enrolment

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

    • A family history of congenital or hereditary immunodeficiency.

    • Major congenital defects or serious chronic illness.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Muntinlupa Philippines 1781
    2 GSK Investigational Site Gdansk Poland 80-394
    3 GSK Investigational Site Lodz Poland 91-347
    4 GSK Investigational Site Trzebnica Poland 55-100
    5 GSK Investigational Site Tuchola Poland 89-500
    6 GSK Investigational Site Wroclaw Poland 50345
    7 GSK Investigational Site Wroclaw Poland 52-312

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00344318
    Other Study ID Numbers:
    • 107007
    First Posted:
    Jun 26, 2006
    Last Update Posted:
    Dec 7, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by GlaxoSmithKline
    Immunogenicity
    Safety
    Pneumococcal vaccine
    Pneumococcal disease
    Additional relevant MeSH terms:
    Streptococcal Infections
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Period Title: Overall Study
    STARTED 300 303 100 103
    COMPLETED 296 298 99 100
    NOT COMPLETED 4 5 1 3

    Baseline Characteristics

    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group Total
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age. Total of all reporting groups
    Overall Participants 300 303 100 103 806
    Age (Weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Weeks]
    7.5
    (1.64)
    7.4
    (1.5)
    7.4
    (1.53)
    7.5
    (1.55)
    7.45
    (1.56)
    Sex: Female, Male (Count of Participants)
    Female
    146
    48.7%
    141
    46.5%
    48
    48%
    46
    44.7%
    381
    47.3%
    Male
    154
    51.3%
    162
    53.5%
    52
    52%
    57
    55.3%
    425
    52.7%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)
    Description Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.
    Time Frame Within 4 day (Days 0-3) after each dose and across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. For reasons of safety analysis related to rectal temperature, subjects were pooled to form the Synflorix Pooled Group and Prevenar Group.
    Arm/Group Title Synflorix Pooled Group Prevenar Pooled Group
    Arm/Group Description Synflorix 1 Group and Synflorix 2 Group pooled together Prevenar 1 Group and Prevenar 2 Group pooled together
    Measure Participants 599 199
    Fever > 39.0°C, post Dose 1
    31
    10.3%
    6
    2%
    Fever > 39.0°C, post Dose 2
    30
    10%
    13
    4.3%
    Fever > 39.0°C, post Dose 3
    42
    14%
    8
    2.6%
    Fever > 39.0°C, across doses
    88
    29.3%
    23
    7.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Synflorix Pooled Group, Prevenar Pooled Group
    Comments Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C after Dose 1 was computed.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 2.17
    Confidence Interval (2-Sided) 95%
    -1.51 to 4.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Synflorix Pooled Group, Prevenar Pooled Group
    Comments Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Towards this, standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C after Dose 2 was computed
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value -1.48
    Confidence Interval () 95%
    -6.05 to 1.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Synflorix Pooled Group, Prevenar Pooled Group
    Comments Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Towards this, standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C after Dose 3 was computed.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 3.05
    Confidence Interval (2-Sided) 95%
    -1.02 to 6.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Synflorix Pooled Group, Prevenar Pooled Group
    Comments Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C across doses was computed.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 3.13
    Confidence Interval (2-Sided) 95%
    -2.65 to 8.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms
    Description Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
    Time Frame Within 4 day (Days 0-3) after each dose and across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 299 300 99 100
    Any Pain, Post Dose 1
    240
    80%
    206
    68%
    76
    76%
    65
    63.1%
    Grade 3 Pain, Post Dose 1
    52
    17.3%
    59
    19.5%
    19
    19%
    17
    16.5%
    Any Redness, Post Dose 1
    126
    42%
    199
    65.7%
    35
    35%
    65
    63.1%
    Grade 3 Redness, Post Dose 1
    10
    3.3%
    30
    9.9%
    6
    6%
    8
    7.8%
    Any Swelling, Post Dose 1
    142
    47.3%
    153
    50.5%
    39
    39%
    56
    54.4%
    Grade 3 Swelling, Post Dose 1
    41
    13.7%
    43
    14.2%
    15
    15%
    9
    8.7%
    Any Pain, Post Dose 2
    191
    63.7%
    186
    61.4%
    55
    55%
    61
    59.2%
    Grade 3 Pain, Post Dose 2
    18
    6%
    31
    10.2%
    8
    8%
    12
    11.7%
    Any Redness, Post Dose 2
    135
    45%
    204
    67.3%
    44
    44%
    59
    57.3%
    Grade 3 Redness, Post Dose 2
    8
    2.7%
    9
    3%
    1
    1%
    2
    1.9%
    Any Swelling, Post Dose 2
    98
    32.7%
    163
    53.8%
    29
    29%
    51
    49.5%
    Grade 3 Swelling, Post Dose 2
    27
    9%
    19
    6.3%
    5
    5%
    5
    4.9%
    Any Pain, Post Dose 3
    168
    56%
    173
    57.1%
    44
    44%
    56
    54.4%
    Grade 3 Pain, Post Dose 3
    14
    4.7%
    23
    7.6%
    1
    1%
    8
    7.8%
    Any Redness, Post Dose 3
    158
    52.7%
    209
    69%
    45
    45%
    70
    68%
    Grade 3 Redness, Post Dose 3
    3
    1%
    8
    2.6%
    0
    0%
    4
    3.9%
    Any Swelling, Post Dose 3
    84
    28%
    151
    49.8%
    25
    25%
    53
    51.5%
    Grade 3 Swelling, Post Dose 3
    15
    5%
    19
    6.3%
    4
    4%
    10
    9.7%
    Any Pain, Across Doses
    258
    86%
    255
    84.2%
    82
    82%
    89
    86.4%
    Grade 3 Pain, Across Doses
    64
    21.3%
    83
    27.4%
    22
    22%
    25
    24.3%
    Any Redness, Across Doses
    221
    73.7%
    265
    87.5%
    67
    67%
    90
    87.4%
    Grade 3 Redness, Across Doses
    18
    6%
    42
    13.9%
    6
    6%
    12
    11.7%
    Any Swelling, Across Doses
    174
    58%
    226
    74.6%
    42
    42%
    75
    72.8%
    Grade 3 Swelling, Across Doses
    57
    19%
    65
    21.5%
    16
    16%
    16
    15.5%
    3. Secondary Outcome
    Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
    Description Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.
    Time Frame Within 4-day (Days 0-3) after each dose and across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 299 300 99 100
    Any Drowsiness, Dose 1
    154
    51.3%
    223
    73.6%
    45
    45%
    75
    72.8%
    G3 Drowsiness, Dose 1
    6
    2%
    10
    3.3%
    3
    3%
    1
    1%
    REL Drowsiness Dose 1
    154
    51.3%
    222
    73.3%
    45
    45%
    75
    72.8%
    Any Fever, Dose 1
    214
    71.3%
    190
    62.7%
    74
    74%
    54
    52.4%
    G3 Fever, Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    REL Fever, Dose 1
    214
    71.3%
    190
    62.7%
    74
    74%
    54
    52.4%
    Any Irritability, Dose 1
    236
    78.7%
    269
    88.8%
    78
    78%
    83
    80.6%
    G3 Irritability, Dose 1
    11
    3.7%
    60
    19.8%
    3
    3%
    17
    16.5%
    REL Irritability, Dose 1
    236
    78.7%
    266
    87.8%
    78
    78%
    83
    80.6%
    Any Loss of appetite, Dose 1
    104
    34.7%
    166
    54.8%
    26
    26%
    52
    50.5%
    G3 Loss of appetite, Dose 1
    1
    0.3%
    1
    0.3%
    1
    1%
    1
    1%
    REL Loss of appetite, Dose 1
    104
    34.7%
    165
    54.5%
    26
    26%
    51
    49.5%
    Any Drowsiness, Dose 2
    102
    34%
    172
    56.8%
    25
    25%
    57
    55.3%
    G3 Drowsiness, Dose 2
    1
    0.3%
    9
    3%
    1
    1%
    2
    1.9%
    REL Drowsiness, Dose 2
    102
    34%
    172
    56.8%
    24
    24%
    56
    54.4%
    Any Fever, Dose 2
    182
    60.7%
    184
    60.7%
    63
    63%
    51
    49.5%
    G3 Fever, Dose 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    REL Fever, Dose 2
    182
    60.7%
    184
    60.7%
    63
    63%
    50
    48.5%
    Any Irritability, Dose 2
    185
    61.7%
    238
    78.5%
    49
    49%
    73
    70.9%
    G3 Irritability, Dose 2
    8
    2.7%
    37
    12.2%
    3
    3%
    9
    8.7%
    REL Irritability, Dose 2
    185
    61.7%
    237
    78.2%
    48
    48%
    72
    69.9%
    Any Loss of appetite, Dose 2
    66
    22%
    117
    38.6%
    20
    20%
    28
    27.2%
    G3 Loss of appetite, Dose 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    REL Loss of appetite, Dose 2
    66
    22%
    116
    38.3%
    19
    19%
    27
    26.2%
    Any Drowsiness, Dose 3
    90
    30%
    152
    50.2%
    25
    25%
    41
    39.8%
    G3 Drowsiness, Dose 3
    2
    0.7%
    5
    1.7%
    0
    0%
    0
    0%
    REL Drowsiness, Dose 3
    90
    30%
    151
    49.8%
    25
    25%
    40
    38.8%
    Any Fever, Dose 3
    147
    49%
    163
    53.8%
    50
    50%
    49
    47.6%
    G3 Fever, Dose 3
    0
    0%
    0
    0%
    0
    0%
    1
    1%
    REL Fever, Dose 3
    147
    49%
    162
    53.5%
    50
    50%
    49
    47.6%
    Any Irritability, Dose 3
    169
    56.3%
    225
    74.3%
    43
    43%
    64
    62.1%
    G3 Irritability, Dose 3
    7
    2.3%
    22
    7.3%
    1
    1%
    2
    1.9%
    REL Irritability, Dose 3
    169
    56.3%
    223
    73.6%
    43
    43%
    64
    62.1%
    Any Loss of appetite, Dose 3
    61
    20.3%
    113
    37.3%
    19
    19%
    19
    18.4%
    G3 Loss of appetite, Dose 3
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    0%
    REL Loss of appetite, Dose 3
    61
    20.3%
    113
    37.3%
    19
    19%
    19
    18.4%
    Any Drowsiness, Across Doses
    184
    61.3%
    256
    84.5%
    56
    56%
    85
    82.5%
    G3 Drowsiness, Across Doses
    9
    3%
    17
    5.6%
    3
    3%
    3
    2.9%
    REL Drowsiness, Across Doses
    184
    61.3%
    256
    84.5%
    56
    56%
    85
    82.5%
    Any Fever, Across Doses
    255
    85%
    261
    86.1%
    88
    88%
    77
    74.8%
    G3 Fever, Across Doses
    0
    0%
    0
    0%
    0
    0%
    1
    1%
    REL Fever, Across Doses
    255
    85%
    261
    86.1%
    88
    88%
    77
    74.8%
    Any Irritability, Across Doses
    258
    86%
    289
    95.4%
    82
    82%
    93
    90.3%
    G3 Irritability, Across Doses
    22
    7.3%
    89
    29.4%
    6
    6%
    24
    23.3%
    REL Irritability, Across Doses
    258
    86%
    289
    95.4%
    82
    82%
    93
    90.3%
    Any Loss of appetite, Across
    140
    46.7%
    221
    72.9%
    39
    39%
    64
    62.1%
    G3 Loss of appetite, Across
    1
    0.3%
    2
    0.7%
    1
    1%
    1
    1%
    REL Loss of appetite, Across
    140
    46.7%
    220
    72.6%
    39
    39%
    63
    61.2%
    4. Secondary Outcome
    Title Number of Subjects With Unsolicited Adverse Events (AEs)
    Description An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
    Time Frame Within 31 days (Days 0-30) after each vaccination

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 300 303 100 103
    Count of Participants [Participants]
    168
    56%
    166
    54.8%
    46
    46%
    61
    59.2%
    5. Secondary Outcome
    Title Number of Subjects With Serious Adverse Events (SAEs)
    Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    Time Frame During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 300 303 100 103
    Count of Participants [Participants]
    6
    2%
    34
    11.2%
    1
    1%
    9
    8.7%
    6. Secondary Outcome
    Title Number of Subjects With Serious Adverse (SAEs)
    Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    Time Frame During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 300 303 100 103
    Count of Participants [Participants]
    16
    5.3%
    52
    17.2%
    4
    4%
    19
    18.4%
    7. Secondary Outcome
    Title Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
    Description Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 285 285 95 96
    Anti-1 POST
    3.23
    1.04
    0.03
    0.03
    Anti-4 POST
    4.96
    1.64
    5.68
    2.14
    Anti-5 POST
    4.87
    1.62
    0.03
    0.03
    Anti-6B POST
    1.19
    0.73
    1.06
    1.23
    Anti-7F POST
    4.84
    2.25
    0.05
    0.04
    Anti-9V POST
    4.04
    1.51
    5.07
    2.7
    Anti-14 POST
    6.45
    3.31
    5.88
    5.23
    Anti-18C POST
    11.56
    3.74
    3.71
    2.64
    Anti-19F POST
    10.46
    5.3
    4.68
    2.38
    Anti-23F POST
    2.23
    1.11
    2.28
    2.2
    8. Secondary Outcome
    Title Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)
    Description Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 285 285 95 96
    Anti-1 POST
    285
    95%
    280
    92.4%
    3
    3%
    3
    2.9%
    Anti-4 POST
    283
    94.3%
    282
    93.1%
    95
    95%
    96
    93.2%
    Anti-5 POST
    285
    95%
    282
    93.1%
    3
    3%
    2
    1.9%
    Anti-6B POST
    260
    86.7%
    244
    80.5%
    82
    82%
    91
    88.3%
    Anti-7F POST
    284
    94.7%
    285
    94.1%
    9
    9%
    5
    4.9%
    Anti-9V POST
    284
    94.7%
    285
    94.1%
    95
    95%
    96
    93.2%
    Anti-14 POST
    285
    95%
    285
    94.1%
    95
    95%
    96
    93.2%
    Anti-18C POST
    284
    94.7%
    281
    92.7%
    95
    95%
    95
    92.2%
    Anti-19F POST
    285
    95%
    282
    93.1%
    94
    94%
    95
    92.2%
    Anti-23F POST
    277
    92.3%
    269
    88.8%
    90
    90%
    95
    92.2%
    9. Secondary Outcome
    Title Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)
    Description Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 285 285 95 96
    Anti-1 POST
    285
    95%
    285
    94.1%
    20
    20%
    13
    12.6%
    Anti-4 POST
    285
    95%
    285
    94.1%
    95
    95%
    96
    93.2%
    Anti-5 POST
    285
    95%
    285
    94.1%
    19
    19%
    13
    12.6%
    Anti-6B POST
    279
    93%
    274
    90.4%
    92
    92%
    91
    88.3%
    Anti-7F POST
    285
    95%
    285
    94.1%
    37
    37%
    22
    21.4%
    Anti-9V POST
    285
    95%
    285
    94.1%
    95
    95%
    96
    93.2%
    Anti-14 POST
    285
    95%
    285
    94.1%
    95
    95%
    96
    93.2%
    Anti-18C POST
    284
    94.7%
    285
    94.1%
    95
    95%
    95
    92.2%
    Anti-19F POST
    285
    95%
    285
    94.1%
    95
    95%
    95
    92.2%
    Anti-23F POST
    285
    95%
    279
    92.1%
    91
    91%
    96
    93.2%
    10. Secondary Outcome
    Title Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
    Description Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 142 145 46 49
    OPA Anti-1
    93.7
    14.8
    4.2
    4
    OPA Anti-4
    1008.7
    602.9
    1229.9
    513
    OPA Anti-5
    209.3
    67.2
    4
    4
    OPA Anti-6B
    963.5
    361.9
    1762.2
    805
    OPA Anti-7F
    5196.4
    2002.2
    14.2
    6.9
    OPA Anti-9V
    1631.9
    1171.7
    1713.3
    1166
    OPA Anti-14
    1669.1
    640
    2117.4
    947.6
    OPA Anti-18C
    673.3
    174.9
    283.7
    127
    OPA Anti-19F
    1121.7
    337.8
    81.6
    35.9
    OPA Anti-23F
    2186.6
    920.6
    4126.6
    3895.4
    11. Secondary Outcome
    Title Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8
    Description Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8.
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 142 145 46 49
    OPA Anti-1
    117
    39%
    62
    20.5%
    1
    1%
    0
    0%
    OPA Anti-4
    137
    45.7%
    143
    47.2%
    43
    43%
    49
    47.6%
    OPA Anti-5
    139
    46.3%
    127
    41.9%
    0
    0%
    0
    0%
    OPA Anti-6B
    132
    44%
    122
    40.3%
    40
    40%
    44
    42.7%
    OPA Anti-7F
    137
    45.7%
    141
    46.5%
    10
    10%
    5
    4.9%
    OPA Anti-9V
    130
    43.3%
    144
    47.5%
    43
    43%
    49
    47.6%
    OPA Anti-14
    138
    46%
    142
    46.9%
    43
    43%
    48
    46.6%
    OPA Anti-18C
    138
    46%
    137
    45.2%
    45
    45%
    48
    46.6%
    OPA Anti-19F
    137
    45.7%
    142
    46.9%
    42
    42%
    45
    43.7%
    OPA Anti-23F
    141
    47%
    132
    43.6%
    42
    42%
    49
    47.6%
    12. Secondary Outcome
    Title Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
    Description Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 285 285 95 96
    Anti-6A
    0.3
    0.17
    0.23
    0.26
    Anti-19A
    0.36
    0.29
    0.18
    0.12
    13. Secondary Outcome
    Title Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL)
    Description Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 285 285 95 96
    Anti-6A
    261
    87%
    230
    75.9%
    84
    84%
    84
    81.6%
    Anti-19A
    169
    56.3%
    164
    54.1%
    90
    90%
    83
    80.6%
    14. Secondary Outcome
    Title Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A
    Description Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 137 143 44 49
    OPA Anti-6A
    93.1
    60.5
    137.3
    175.1
    OPA Anti-19A
    10.6
    10.1
    4.2
    4
    15. Secondary Outcome
    Title Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8
    Description Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 137 143 44 49
    OPA Anti-6A
    91
    30.3%
    83
    27.4%
    34
    34%
    36
    35%
    OPA Anti-19A
    35
    11.7%
    41
    13.5%
    1
    1%
    0
    0%
    16. Secondary Outcome
    Title Concentrations of Antibodies Against Protein D (Anti-PD)
    Description Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 284 285 95 96
    Geometric Mean (95% Confidence Interval) [EL.U/mL]
    3800
    2002
    105.2
    66.6
    17. Secondary Outcome
    Title Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL)
    Description Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.
    Time Frame One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 284 285 95 96
    Count of Participants [Participants]
    284
    94.7%
    285
    94.1%
    39
    39%
    18
    17.5%
    18. Secondary Outcome
    Title Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL)
    Description Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects.
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 140 140 49 47
    Count of Participants [Participants]
    140
    46.7%
    140
    46.2%
    49
    49%
    47
    45.6%
    19. Secondary Outcome
    Title Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
    Description Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects.
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 140 140 49 47
    Count of Participants [Participants]
    139
    46.3%
    137
    45.2%
    48
    48%
    45
    43.7%
    20. Secondary Outcome
    Title Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
    Description Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 140 140 49 47
    Geometric Mean (95% Confidence Interval) [μg/mL]
    26.001
    9.376
    25.758
    8.86
    21. Secondary Outcome
    Title Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
    Description Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects.
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 140 140 49 47
    Anti-diphtheria
    137
    45.7%
    140
    46.2%
    49
    49%
    46
    44.7%
    Anti-tetanus
    139
    46.3%
    140
    46.2%
    48
    48%
    47
    45.6%
    22. Secondary Outcome
    Title Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
    Description Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 140 140 49 47
    Anti-diphtheria
    1.735
    1.549
    1.252
    1.039
    Anti-tetanus
    5.195
    3.505
    3.476
    2.659
    23. Secondary Outcome
    Title Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL)
    Description Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects.
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 140 133 49 44
    Count of Participants [Participants]
    127
    42.3%
    132
    43.6%
    44
    44%
    44
    42.7%
    24. Secondary Outcome
    Title Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
    Description Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 140 133 49 44
    Geometric Mean (95% Confidence Interval) [mIU/mL]
    101.6
    756.7
    129.8
    792.2
    25. Secondary Outcome
    Title Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8
    Description Titers were expressed as geometric mean titres (GMTs).
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 124 120 44 41
    Anti-polio 1
    120
    40%
    120
    39.6%
    40
    40%
    40
    38.8%
    Anti-polio 2
    124
    41.3%
    115
    38%
    43
    43%
    41
    39.8%
    Anti-polio 3
    116
    38.7%
    107
    35.3%
    32
    32%
    39
    37.9%
    26. Secondary Outcome
    Title Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers
    Description Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 124 120 44 41
    Anti-polio 1
    641.5
    331.1
    373.7
    267.6
    Anti-polio 2
    523.6
    276.8
    546.2
    303.5
    Anti-polio 3
    204.5
    540.8
    101.9
    611.5
    27. Secondary Outcome
    Title Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity)
    Description Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination.
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 138 133 48 45
    Count of Participants [Participants]
    137
    45.7%
    126
    41.6%
    47
    47%
    42
    40.8%
    28. Secondary Outcome
    Title Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations
    Description Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL.
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 128 119 46 41
    Geometric Mean (95% Confidence Interval) [EL.U/mL]
    72.465
    53.481
    77.175
    60.003
    29. Secondary Outcome
    Title Number of Subjects With Vaccine Response to Bordetella Pertussis
    Description Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations < 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL).
    Time Frame One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    Measure Participants 128 119 46 41
    S-
    127
    42.3%
    112
    37%
    46
    46%
    38
    36.9%
    S+
    9
    3%
    12
    4%
    1
    1%
    2
    1.9%

    Adverse Events

    Time Frame Solicited AEs: Within 4 day (Days 0-3) after each dose and across doses; Unsolicited AEs: Within 31 days (Days 0-30) after each vaccination. SAEs: From study Day 0 until the 6-month extended safety follow-up
    Adverse Event Reporting Description
    Arm/Group Title Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Arm/Group Description Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.
    All Cause Mortality
    Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/300 (0%) 0/303 (0%) 0/100 (0%) 0/103 (0%)
    Serious Adverse Events
    Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 16/300 (5.3%) 52/303 (17.2%) 4/100 (4%) 19/103 (18.4%)
    Blood and lymphatic system disorders
    Microcytic anaemia 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Thrombocytopenic purpura 0/300 (0%) 0 0/303 (0%) 0 0/100 (0%) 0 1/103 (1%) 1
    Congenital, familial and genetic disorders
    Atrial septal defect 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Double ureter 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Gastrointestinal disorders
    Aphthous stomatitis 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Diarrhoea 0/300 (0%) 0 2/303 (0.7%) 2 0/100 (0%) 0 3/103 (2.9%) 3
    Dyspepsia 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Enteritis 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Enterocolitis 0/300 (0%) 0 4/303 (1.3%) 4 0/100 (0%) 0 1/103 (1%) 1
    Gastritis 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Gastrooesophageal reflux disease 0/300 (0%) 0 3/303 (1%) 3 0/100 (0%) 0 0/103 (0%) 0
    General disorders
    Ill-defined disorder 0/300 (0%) 0 0/303 (0%) 0 0/100 (0%) 0 1/103 (1%) 1
    Pyrexia 1/300 (0.3%) 1 1/303 (0.3%) 1 0/100 (0%) 0 1/103 (1%) 1
    Immune system disorders
    Milk allergy 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Infections and infestations
    Bacterial infection 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 1/103 (1%) 1
    Bronchitis 0/300 (0%) 0 14/303 (4.6%) 16 0/100 (0%) 0 2/103 (1.9%) 2
    Bronchopneumonia 2/300 (0.7%) 2 0/303 (0%) 0 0/100 (0%) 0 2/103 (1.9%) 2
    Dengue fever 1/300 (0.3%) 1 0/303 (0%) 0 0/100 (0%) 0 0/103 (0%) 0
    Gastroenteritis 5/300 (1.7%) 5 9/303 (3%) 9 2/100 (2%) 2 2/103 (1.9%) 2
    Gastroenteritis rotavirus 0/300 (0%) 0 3/303 (1%) 3 0/100 (0%) 0 3/103 (2.9%) 3
    Gastrointestinal infection 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Laryngitis 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Nasopharyngitis 0/300 (0%) 0 3/303 (1%) 4 0/100 (0%) 0 0/103 (0%) 0
    Otitis media 0/300 (0%) 0 3/303 (1%) 3 0/100 (0%) 0 2/103 (1.9%) 2
    Paronychia 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Pharyngitis 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 1/103 (1%) 1
    Pneumonia 7/300 (2.3%) 7 8/303 (2.6%) 8 1/100 (1%) 1 3/103 (2.9%) 3
    Pneumonia mycoplasmal 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Pyelonephritis acute 0/300 (0%) 0 2/303 (0.7%) 2 0/100 (0%) 0 0/103 (0%) 0
    Respiratory tract infection 0/300 (0%) 0 2/303 (0.7%) 2 0/100 (0%) 0 0/103 (0%) 0
    Rhinitis 0/300 (0%) 0 2/303 (0.7%) 2 0/100 (0%) 0 0/103 (0%) 0
    Upper respiratory tract infection 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Urinary tract infection 0/300 (0%) 0 4/303 (1.3%) 4 1/100 (1%) 1 1/103 (1%) 1
    Urosepsis 0/300 (0%) 0 0/303 (0%) 0 0/100 (0%) 0 1/103 (1%) 1
    Injury, poisoning and procedural complications
    Contusion 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Head injury 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Investigations
    Hepatic enzyme increased 0/300 (0%) 0 0/303 (0%) 0 0/100 (0%) 0 1/103 (1%) 1
    Metabolism and nutrition disorders
    Dehydration 2/300 (0.7%) 2 0/303 (0%) 0 2/100 (2%) 2 0/103 (0%) 0
    Iron deficiency 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Nervous system disorders
    Febrile convulsion 0/300 (0%) 0 2/303 (0.7%) 2 0/100 (0%) 0 0/103 (0%) 0
    Renal and urinary disorders
    Nephrotic syndrome 0/300 (0%) 0 1/303 (0.3%) 1 0/100 (0%) 0 0/103 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity 2/300 (0.7%) 2 0/303 (0%) 0 0/100 (0%) 0 0/103 (0%) 0
    Bronchitis chronic 0/300 (0%) 0 3/303 (1%) 3 0/100 (0%) 0 1/103 (1%) 1
    Pneumonitis 0/300 (0%) 0 2/303 (0.7%) 2 0/100 (0%) 0 0/103 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic 0/300 (0%) 0 0/303 (0%) 0 0/100 (0%) 0 1/103 (1%) 1
    Rash 1/300 (0.3%) 1 0/303 (0%) 0 0/100 (0%) 0 0/103 (0%) 0
    Other (Not Including Serious) Adverse Events
    Synflorix 1 Group Synflorix 2 Group Prevenar 1 Group Prevenar 2 Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 296/300 (98.7%) 300/303 (99%) 95/100 (95%) 98/103 (95.1%)
    Gastrointestinal disorders
    Diarrhoea 0/300 (0%) 0 7/303 (2.3%) 10 0/100 (0%) 0 8/103 (7.8%) 9
    General disorders
    Pain 258/300 (86%) 599 86/303 (28.4%) 193 82/100 (82%) 175 89/103 (86.4%) 182
    Pyrexia 255/300 (85%) 543 262/303 (86.5%) 542 88/100 (88%) 187 77/103 (74.8%) 155
    Swelling 174/300 (58%) 324 226/303 (74.6%) 467 42/100 (42%) 93 75/103 (72.8%) 160
    Infections and infestations
    Bronchitis 9/300 (3%) 9 6/303 (2%) 6 0/100 (0%) 0 6/103 (5.8%) 7
    Gastroenteritis 17/300 (5.7%) 19 3/303 (1%) 3 7/100 (7%) 7 0/103 (0%) 0
    Nasopharyngitis 0/300 (0%) 0 10/303 (3.3%) 14 0/100 (0%) 0 4/103 (3.9%) 4
    Pharyngitis 4/300 (1.3%) 4 17/303 (5.6%) 18 2/100 (2%) 2 3/103 (2.9%) 4
    Rhinitis 38/300 (12.7%) 42 39/303 (12.9%) 43 7/100 (7%) 10 9/103 (8.7%) 9
    Upper respiratory tract infection 84/300 (28%) 97 16/303 (5.3%) 17 25/100 (25%) 31 12/103 (11.7%) 13
    Urinary tract infection 0/300 (0%) 0 8/303 (2.6%) 8 0/100 (0%) 0 0/103 (0%) 0
    Viral infection 11/300 (3.7%) 11 1/303 (0.3%) 1 4/100 (4%) 4 0/103 (0%) 0
    Viral rhinitis 15/300 (5%) 16 0/303 (0%) 0 2/100 (2%) 2 0/103 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 140/300 (46.7%) 231 79/303 (26.1%) 152 39/100 (39%) 65 64/103 (62.1%) 99
    Nervous system disorders
    Somnolence 184/300 (61.3%) 346 256/303 (84.5%) 547 56/100 (56%) 95 85/103 (82.5%) 173
    Psychiatric disorders
    Irritability 258/300 (86%) 590 289/303 (95.4%) 732 82/100 (82%) 170 93/103 (90.3%) 221
    Skin and subcutaneous tissue disorders
    Erythema 221/300 (73.7%) 420 265/303 (87.5%) 360 67/100 (67%) 124 91/103 (88.3%) 195
    Vascular disorders
    Haematoma 11/300 (3.7%) 11 0/303 (0%) 0 1/100 (1%) 1 0/103 (0%) 0

    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.

    Results Point of Contact

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00344318
    Other Study ID Numbers:
    • 107007
    First Posted:
    Jun 26, 2006
    Last Update Posted:
    Dec 7, 2018
    Last Verified:
    May 1, 2018