- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276107
Study Evaluating Prevenar Vaccine in Healthy Infants
July 28, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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.
Study Overview
Study Type
Interventional
Enrollment
200
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 3 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Study Completion
December 1, 2005
Study Registration Dates
First Submitted
January 11, 2006
First Submitted That Met QC Criteria
January 11, 2006
First Posted (Estimate)
January 12, 2006
Study Record Updates
Last Update Posted (Estimate)
July 29, 2009
Last Update Submitted That Met QC Criteria
July 28, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0887X-101446
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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