Phase 3
Completed N=1,866
Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
Pneumococcal Infections
Source: ClinicalTrials.gov NCT00508742 ↗
Enrolled (actual)
1,866
Serious AEs
6.0%
Results posted
Jul 2012
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.