Phase 3
N=1,866
Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00508742 ↗Enrolled (actual)
1,866
Serious AEs
6.0%
Results posted
Jul 2012
Primary outcome: Primary: Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age — 20.0; 36.0 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)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age |
20.0; 36.0 | — |
| SECONDARY Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age |
7.3; 10.9; 8.1; 13.7; 5.4; 13.6 | — |
Summary
This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.
Eligibility Criteria
Inclusion Criteria
- Healthy infants aged 2 months (42-98 days) at time of enrolment.
- Available for the entire study period and whose parent/legal guardian can be reached by telephone.
Exclusion Criteria
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with a pneumococcal conjugate vaccine.
Data sourced from ClinicalTrials.gov (NCT00508742). 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.