Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. (IVANHOE)
|ClinicalTrials.gov Identifier: NCT00740935|
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : October 22, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Rotavirus Gastroenteritis||Biological: Rotateq vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7204 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.|
|Study Start Date :||May 2007|
|Primary Completion Date :||December 2010|
|Study Completion Date :||June 2011|
Cohort of vaccinated infants against rotavirus
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
- Hospitalization for gastroenteritis [ Time Frame: 2 years ]
- Emergency department consultation for gastroenteritis [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740935
|Clinical Investigation Center|
|Brest, France, 29200|
|Study Director:||Arnaud GAGNEUR, Doctor||University Hospital, Brest|