- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368186
Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.
Study Overview
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Paris, France, 75019
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis.
Exclusion Criteria
Previous immunization with pneumococcal-containing vaccines.
History of pneumococcal invasive disease (meningitis, bacteremia, pneumonia).
Known or suspected impairments of the immune system (including HIV infection) or recipients of immuno-suppressant agents.
Other Exclusions apply.
Study Plan
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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Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.
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Secondary Outcome Measures
Outcome Measure |
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Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0877X-100722
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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