Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL

Inclusion criteria

• Healthy infants 2 months of age.
• Infants with at least 37 weeks of gestation at delivery.
• Signed informed consent from parent or guardian.
• Able to attend the scheduled visits and to comply with the study procedure.
• Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.

Exclusion criteria

• Clinically significant findings on review of systems or physical examination (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 HIV-positive mother.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay or neurologic disorders.
• Chronic medical, congenital, developmental or surgical disease.
• Participation in any other experimental vaccine trial.
• Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
• Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine