At a glance
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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
In Brief
A Phase 3 clinical trial evaluating 13-valent Pneumococcal Conjugate Vaccine and 7-valent pneumococcal conjugate vaccine for Vaccines, Pneumococcal Conjugate Vaccine. Completed, enrolled 603 participants across 11 sites.
Detailed 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.
Study Details
Timeline
Interventions
13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.