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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00368186 |
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Date of registration:
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21/08/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
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Scientific title:
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An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants. |
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Date of first enrolment:
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May 2001 |
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Target sample size:
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51 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00368186 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
57 Days
Age maximum:
112 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pneumococcal Infections
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Intervention(s)
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Biological: Pneumo 23
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Primary Outcome(s)
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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(s)
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Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.
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Secondary ID(s)
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0877X-100722
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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