Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Inclusion Criteria:

• Healthy 2 to 6 month-old infant
• Available for entire study period

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with a pneumococcal conjugate vaccine.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
• Known or suspected immune deficiency or suppression.