13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study 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.

• Biological: 13-valent pneumococcal conjugate vaccine
  
  Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
• Biological: 13-valent pneumococcal conjugate vaccine
  
  Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

• Experimental: Multidose Vial Group
  
  Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL
  Intervention: Biological: 13-valent pneumococcal conjugate vaccine
• Active Comparator: Single-Dose Syringe Group
  
  Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL
  Intervention: Biological: 13-valent pneumococcal conjugate vaccine

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