NCT00475033

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Canada

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 603 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 42 Days – 98 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Conditions

• Vaccines, Pneumococcal Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
BIOLOGICAL	7-valent pneumococcal conjugate vaccine	7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-05-17
• Last updated: 2011-04-21
• Results posted: 2010-06-04

Locations

11 sites across 1 country: Canada