Study Evaluating Prevenar Vaccine in Healthy Infants

Wyeth is now a wholly owned subsidiary of Pfizer200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Pneumococcal Infections

Interventions

PrevenarBIOLOGICAL

Eligibility

Sex: ALLMin age: 42 DaysMax age: 100 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.