Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. (IVANHOE)
| Tracking Information | |||||
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| First Received Date ICMJE | August 22, 2008 | ||||
| Last Updated Date | February 20, 2012 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hospitalization for gastroenteritis [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00740935 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Emergency department consultation for gastroenteritis [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. | ||||
| Official Title ICMJE | Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. | ||||
| Brief Summary | Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners. Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units of Brest University Hospital with systematic testing for Rotavirus. Evaluation of the impact of the vaccination program on rotaviral gastroenteritis hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from 2002-2007 in the absence of vaccination. The principal judgement criterion is the number of pediatric hospitalizations for rotaviral GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the suburbs of Brest. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Rotavirus Gastroenteritis | ||||
| Intervention ICMJE | Biological: Rotateq vaccine
Vaccination against rotavirus Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose. Other Name: Rotateq |
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| Study Arm (s) | 1
Cohort of vaccinated infants against rotavirus
Intervention: Biological: Rotateq vaccine |
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| Publications * | Gagneur A, Nowak E, Lemaitre T, Segura JF, Delaperrière N, Abalea L, Poulhazan E, Jossens A, Auzanneau L, Tran A, Payan C, Jay N, de Parscau L, Oger E; IVANHOE investigators. Impact of rotavirus vaccination on hospitalizations for rotavirus diarrhea: the IVANHOE study. Vaccine. 2011 May 12;29(21):3753-9. Epub 2011 Apr 13. | ||||
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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 | 7204 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Weeks to 12 Weeks | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00740935 | ||||
| Other Study ID Numbers ICMJE | RB 06.117 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University Hospital, Brest | ||||
| Study Sponsor ICMJE | University Hospital, Brest | ||||
| Collaborators ICMJE | Sanofi Pasteur MSD | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Brest | ||||
| Verification Date | September 2010 | ||||
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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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