Study Evaluating Prevenar Vaccine in Healthy Infants

Wyeth

Status and phase: Completed; Phase 4

Conditions: Pneumococcal Infections

Treatments: Biological: Prevenar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276107

0887X-101446

Details and patient eligibility

About

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.

Sex: All

Ages: 42 to 100 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)