Safety and Local Tolerability of Prevenar in Indian Children

INCLUSION CRITERIA

Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:

For Primary Immunization Schedule:

• Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination
• For Catch-up Immunization Schedule:
• Healthy male or female subjects 12-23 months of age

EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.

• A known or suspected history of Streptococcus pneumoniae disease.
• A previous anaphylactic or other severe vaccine-associated adverse event.
• A known or suspected impairment of immune system (including HIV infection), or recipient of immunosuppressive agents.
• A major congenital, developmental or serious chronic disorder.
• A confirmed or suspected underlying evolving neurological disorder or history of seizures.
• A history of thrombocytopenia or any coagulation disorder.
• Any acute illness at the time of vaccine administration