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

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.

本研究旨在评估13价肺炎球菌结合疫苗（13-valent pneumococcal conjugate vaccine）与加拿大儿童常规疫苗联合接种时，在健康婴儿中的安全性、耐受性与免疫原性。本研究将考察：当与该13价肺炎球菌结合疫苗联合接种时，儿童常规疫苗的婴儿接种程序（含NeisVac-C®与Pentacel®）及幼儿剂量（NeisVac-C®）所诱导的免疫应答，相较于与7价肺炎球菌结合疫苗（7-valent pneumococcal conjugate vaccine）联合接种时的免疫应答是否具有非劣效性。此外，本研究还将评估该13价肺炎球菌结合疫苗的安全性特征与免疫原性。