13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

Inclusion Criteria:

• Aged 42 to 70 days at enrollment.
• Determined by medical history, physical examination, and clinical judgment to be eligible for the study
• Weight of 3.5 kg or greater at the time of enrollment

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with pneumococcal conjugate vaccine.
• Receipt of blood products or gamma-globulin since birth