Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. (IVANHOE)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.|
- Hospitalization for gastroenteritis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Emergency department consultation for gastroenteritis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740935
|Clinical Investigation Center|
|Brest, France, 29200|
|Study Director:||Arnaud GAGNEUR, Doctor||University Hospital, Brest|