Study Evaluating Prevenar Vaccine in Healthy Infants

An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age

To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.

Inclusion Criteria:

• Healthy male and female children 2 months of age (42 to 100 days) in good health.
• An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
• Infants whose parent(s)/guardian(s) will be available for the entire study period.

Exclusion Criteria:

• Hypersensitivity to any component of the vaccine, including diphtheria toxoid
• Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
• Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.

Other exclusions apply.