Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
Condition: Diphtheria; Tetanus; Haemophilus Infection; Pertussis; Polio
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections
Intervention: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®; Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1167.0
Sex: All
Minimum age: 42 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pertussis; Whooping cough; Diphtheria; Tetanus; Haemophilus influenzae; Poliovirus Types 1, 2, and 3.

Summary:

      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®.
    

Eligibility criteria:

        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.