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

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.

Inclusion Criteria:

• Healthy 2-month old infants (42 to 98 days)
• Available for the duration of the study and reachable by telephone

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
• Previous anaphylactic reaction to any vaccine or vaccine-related component.
• Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
• Receipt of blood products or gamma globulin