Status:
COMPLETED
Study Evaluating Prevenar Vaccine in Healthy Infants
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
42-100 years
Phase:
PHASE4
Brief Summary
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00276107
Start Date
December 1 2004
End Date
December 1 2005
Last Update
July 29 2009
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