A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus Pneumoniae in Healthy Infants in Israel.

Pfizer2 sites in 1 country1,866 target enrollmentDecember 2007

ConditionsPneumococcal Infections

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pneumococcal Infections
Sponsor: Pfizer
Enrollment: 1866
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

August 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: Month 7 through Month 24

A new acquisition was defined as the detection of a serotype (here 6A' \[6A + 6C\] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.

Secondary Outcomes

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(Month 7, 12, 13, 18, 24)