Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™

Primary Objective - Stage I:

To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).

Primary Objective - Stage II:

To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.

Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.

Inclusion Criteria :

• Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
• Infants with at least 36 weeks of gestation at delivery.
• Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
• Able to attend the scheduled visits and to comply with the study procedures.
• Parent or legal guardian willing to take rectal temperatures during the infant series.
• Parent or legal guardian has access to a telephone.
• Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
• Able to obtain at least 1.5 mL of blood sample prior to Dose 1.

Exclusion Criteria :

• Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
• Known or suspected hypersensitivity to any component of the study vaccine to be administered.
• Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
• Known Human Immunodeficiency Virus (HIV)-positive mother or child.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay or neurologic disorder.
• Chronic medical, congenital, or developmental disease.
• Participation in any other clinical trial.
• Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
• Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.