Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac
This study has been completed.
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00450554
First received: March 19, 2007
Last updated: March 26, 2012
Last verified: March 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 19, 2007 | ||||
| Last Updated Date | March 26, 2012 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00450554 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac | ||||
| Official Title ICMJE | EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE DE NEISSERIA MENINGITIDIS B:14,P1.7,16 | ||||
| Brief Summary | The main objective of the study is to estimate the proportion of children, born between the 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before and after the third MenBvac vaccination. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville |
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| Condition ICMJE | Vaccination | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 236 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 7 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00450554 | ||||
| Other Study ID Numbers ICMJE | 2007/004/HP | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University Hospital, Rouen | ||||
| Study Sponsor ICMJE | University Hospital, Rouen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Rouen | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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