Phase 3
N=709
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00452790 ↗Enrolled (actual)
709
Serious AEs
2.1%
Results posted
Nov 2010
Primary outcome: Primary: Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series. — 97.0; 97.9; 84.7; 87.1 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)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series. |
97.0; 97.9; 84.7; 87.1; 92.6; 94.4 | — |
| PRIMARY Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series. |
100.0; 100.0; 100.0; 100.0; 92.7; 95.9 | — |
| SECONDARY Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose. |
100.0; 100.0; 100.0; 99.5; 99.5; 99.5 | — |
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
Eligibility Criteria
Inclusion Criteria
- Healthy infants aged 6 weeks (42-72 days) at time of enrolment
- Available for the entire study period
Exclusion Criteria
- Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
- A previous anaphylactic reaction to any vaccine or vaccine-related component
- Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Data sourced from ClinicalTrials.gov (NCT00452790). 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.