Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
NCT00368186
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Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis.
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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants. | |||
| Official Title ICMJE | An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants. | |||
| Brief Summary | The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
| Condition ICMJE | Pneumococcal Infections | |||
| Intervention ICMJE | Biological: Pneumo 23 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Enrollment ICMJE | 51 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | November 2002 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | 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. | |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 57 Days to 112 Days (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00368186 | |||
| Other Study ID Numbers ICMJE | 0877X-100722 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | August 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||