Phase 3
N=613
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Vaccines, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT00366678 ↗Enrolled (actual)
613
Serious AEs
1.5%
Results posted
Aug 2012
Primary outcome: Primary: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group — 100.0; 100.0; 100.0; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological); 7-valent pneumococcal conjugate vaccine (Biological); Pentavac (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group |
100.0; 100.0; 100.0; 100.0; 94.3; 95.0 | — |
| PRIMARY Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group |
0.19; 0.24; 2.09; 2.60; 0.20; 0.21 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group |
1.28; 1.40; 12.15; 11.68 | — |
| PRIMARY Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group |
24.99; 28.33; 253.05; 250.56; 17.75; 21.55 | — |
| PRIMARY Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group |
97.12; 111.23; 204.28; 241.08; 62.94; 68.20 | — |
| PRIMARY Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC |
91.4; 72.6; 92.9; 94.9; 90.5; 97.9 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions |
38.3; 38.5; 33.2; 42.2; 36.2; 32.0 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events |
13.5; 10.0; 19.8; 25.3; 26.9; 27.9 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC |
1.29; 0.74; 1.15; 2.74; 1.42; 1.55 | — |
| SECONDARY Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups |
100.0; 100.0; 99.1; 99.6; 99.2; 98.1 | — |
| SECONDARY Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups |
0.3; 4.2; 0.5; 4.8; 0.5; 4.0 | — |
| SECONDARY Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups |
100.0; 98.9; 100.0; 97.8; 100.0; 97.8 | — |
| SECONDARY Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose |
126.00; 61.58; 345.33; 428.88; 244.18; 130.99 | — |
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.
Eligibility Criteria
Inclusion Criteria
- Healthy 2-month-old infants.
- Available for the entire study period.
Exclusion criteria
· Known contraindication to vaccines.
Data sourced from ClinicalTrials.gov (NCT00366678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.