Phase 3
N=666
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
Vaccines, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT00373958 ↗Enrolled (actual)
666
Serious AEs
2.6%
Results posted
Feb 2013
Primary outcome: Primary: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series — 94.4; 98.0; 87.3; 92.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13 valent pneumococcal conjugate vaccine (Biological); 7vPnc pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series |
94.4; 98.0; 87.3; 92.8; 90.5; 98.4 | — |
| PRIMARY Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose |
3.73; 5.49; 11.53; 15.63; 2.62; 3.63 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series |
97.9; 97.8; 77.6; 78.3; 95.7; 96.1 | — |
| PRIMARY Percentage of Participants Reporting Pre-specified Systemic Events |
24.0; 21.2; 43.2; 40.4; 39.8; 37.7 | — |
| PRIMARY Percentage of Participants Reporting Pre-specified Local Reactions |
72.7; 72.2; 77.0; 75.9; 78.7; 80.9 | — |
| SECONDARY Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib) |
96.4; 97.1; 76.5; 72.9; 91.9; 90.7 | — |
| SECONDARY Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
6.84; 7.30 | — |
| SECONDARY Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
1.98; 2.06; 1.32; 1.32; 0.74; 0.73 | — |
| SECONDARY Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
76.53; 97.69 | — |
| SECONDARY Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose |
97.8; 98.9; 98.9; 98.9; 98.9; 100.0 | — |
| SECONDARY Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose |
359.32; 535.68; 1179.98; 1492.46; 1054.65; 1513.66 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.
Eligibility Criteria
Inclusion Criteria
- Healthy 2-month-old infants.
- Available for the entire study period.
Exclusion criteria
- Previous vaccination with any vaccine before the start of the study.
- Known contraindication to vaccination.
Data sourced from ClinicalTrials.gov (NCT00373958). 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.