Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Pertussis, Polio
Conditions
Keywords
Hepatitis B, Polio, Diphtheria, Pertussis, H. influenzae type b
Brief summary
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth. Primary Objective: To demonstrate that the hexavalent DTaP-IPV-HB-PRP\ T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar® Secondary Objectives: Immunogenicity: To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP\ T and Infanrix™-Hexa) one month after the third dose of the primary series. Safety: To describe the overall safety after each injection.
Interventions
0.5 mL, IM
0.5 mL, IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Days to 71 Days
Healthy volunteers
Yes
Inclusion criteria
: * Two month old infant (50 to 71 days old) on the day of inclusion, of either gender. * Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg. * Hepatitis B vaccination since birth. * Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate. * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
: * Participation in another clinical trial in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances. * Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy. * Chronic illness at a stage that could interfere with trial conduct or completion. * Blood or blood-derived products received since birth. * Any vaccination in the 4 weeks preceding the first trial vaccination. * Any planned vaccination (except trial vaccinations) during the trial. * Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically). * Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae. * Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity. * Known thrombocytopenia or bleeding disorder contraindicating IM vaccination. * History of seizures. * Febrile (rectal equivalent temperature \>= 38.0°C) or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Day 150 post-dose 1 | Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Day 150 post-dose 1 | Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL. |
| Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Day 150 post-dose 1 | Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil |
| Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Day 150 post-dose 1 | Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline. |
| Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Day 150 post-dose 1 | Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Day 0 up to Day 7 post-vaccination | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3: Pyrexia, \>39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable. |
Countries
Thailand
Participant flow
Recruitment details
Participants were enrolled from 22 October 2006 to 19 November 2007 in 4 clinical centers in Thailand.
Pre-assignment details
A total of 412 participants who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV-Hep B-PRP-T + Prevnar™ Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | 206 |
| Infanrix Hexa™ + Prevnar™ Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | 206 |
| Total | 412 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 7 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Infanrix Hexa™ + Prevnar™ | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 206 Participants | 206 Participants | 412 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Age Continuous | 1.90 Months STANDARD_DEVIATION 0.187 | 1.88 Months STANDARD_DEVIATION 0.17 | 1.89 Months STANDARD_DEVIATION 0.179 |
| Region of Enrollment Thailand | 206 Participants | 206 Participants | 412 Participants |
| Sex: Female, Male Female | 111 Participants | 94 Participants | 205 Participants |
| Sex: Female, Male Male | 95 Participants | 112 Participants | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 161 / 206 | 135 / 206 |
| serious Total, serious adverse events | 6 / 206 | 8 / 206 |
Outcome results
Primary
Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
Time frame: Day 150 post-dose 1
Population: Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Hepatitis B (N = 188, 190) | 187 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-PRP (N = 189, 190) | 183 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Hepatitis B (N = 188, 190) | 189 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-PRP (N = 189, 190) | 183 Participants |
Secondary
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
Time frame: Day 150 post-dose 1
Population: Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-PRP (N = 189, 190) | 5.07 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Polio Type 2 (N = 187, 186) | 1489 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Tetanus (N = 189, 190) | 1.38 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Polio Type 3 (N = 187, 186) | 837 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Diphtheria (N = 189, 190) | 0.297 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Pertussis toxoid (N = 189, 189) | 168 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Polio Type 1 (N = 187, 186) | 765 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Filamentous hemagglutinin (N = 188, 188) | 148 Titers |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Hepatitis B (N = 188, 190) | 2477 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Filamentous hemagglutinin (N = 188, 188) | 123 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Hepatitis B (N = 188, 190) | 2442 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-PRP (N = 189, 190) | 2.41 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Diphtheria (N = 189, 190) | 0.209 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Tetanus (N = 189, 190) | 1.83 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Polio Type 1 (N = 187, 186) | 1566 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Polio Type 2 (N = 187, 186) | 2277 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Polio Type 3 (N = 187, 186) | 2029 Titers |
| Infanrix Hexa™ + Prevnar™ | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Pertussis toxoid (N = 189, 189) | 200 Titers |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3: Pyrexia, \>39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-dose 1 | 161 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-dose 2 | 136 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-dose 3 | 119 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-any dose | 180 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Pain Post-any dose | 20 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-dose 1 | 79 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-dose 2 | 93 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-dose 3 | 86 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-any dose | 121 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Erythema Post-any dose | 3 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-dose 1 | 59 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-dose 2 | 52 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-dose 3 | 34 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-any dose | 85 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Swelling Post-any dose | 1 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-dose 1 | 109 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-dose 2 | 84 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-dose 3 | 81 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-any dose | 152 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Pyrexia Post-any dose | 6 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post Dose 1 | 47 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post-dose 2 | 28 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post-dose 3 | 22 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post-any dose | 77 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Vomiting Post-any dose | 1 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-dose 1 | 128 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-dose 2 | 106 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-dose 3 | 77 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-any dose | 167 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Crying Post-any dose | 7 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-dose 1 | 109 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-dose 2 | 91 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-dose 3 | 55 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-any dose | 141 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Somnolence post-any dose | 4 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-dose 1 | 59 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-dose 2 | 44 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-dose 3 | 36 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-any dose | 91 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Anorexia Post-any dose | 0 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-dose 1 | 134 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-dose 2 | 107 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-dose 3 | 90 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-any dose | 162 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Irritability Post-any dose | 4 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post-dose 3 | 28 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-dose 1 | 135 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Anorexia Post-any dose | 0 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-dose 2 | 118 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post-any dose | 82 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-dose 3 | 112 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Somnolence post-any dose | 0 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pain Post-any dose | 166 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Vomiting Post-any dose | 3 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Pain Post-any dose | 12 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-dose 3 | 88 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-dose 1 | 64 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-dose 1 | 106 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-dose 2 | 91 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-dose 1 | 49 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-dose 3 | 79 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-dose 2 | 104 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Erythema Post-any dose | 114 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-dose 1 | 122 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Erythema Post-any dose | 2 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-dose 3 | 75 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-dose 1 | 34 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-dose 2 | 40 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-dose 2 | 44 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Crying Post-any dose | 153 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-dose 3 | 32 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Irritability Post-any dose | 6 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Swelling Post-any dose | 65 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Crying Post-any dose | 5 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Swelling Post-any dose | 1 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-dose 3 | 37 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-dose 1 | 68 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-dose 1 | 104 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-dose 2 | 79 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-dose 2 | 109 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-dose 3 | 81 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-dose 2 | 79 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Pyrexia Post-any dose | 131 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anorexia Post-any dose | 83 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Grade 3 Pyrexia Post-any dose | 7 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-dose 3 | 59 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post Dose 1 | 56 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Irritability Post-any dose | 159 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Vomiting Post-dose 2 | 32 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Somnolence Post-any dose | 125 Participants |
Secondary
Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
Time frame: Day 150 post-dose 1
Population: Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-pertussis toxoid (N = 189, 189) | 177 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Filamentous hemagglutinin (N = 187, 188) | 177 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-pertussis toxoid (N = 189, 189) | 177 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Filamentous hemagglutinin (N = 187, 188) | 179 Participants |
Secondary
Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
Time frame: Day 150 post-dose 1
Population: Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Diphtheria | 184 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Tetanus | 189 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Diphtheria | 190 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti-Tetanus | 190 Participants |
Secondary
Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
Time frame: Day 150 post-dose 1
Population: Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti Polio Type 1 | 187 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti Polio Type 2 | 187 Participants |
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti Polio Type 3 | 187 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti Polio Type 2 | 186 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti Polio Type 1 | 186 Participants |
| Infanrix Hexa™ + Prevnar™ | Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ | Anti Polio Type 3 | 185 Participants |