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Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.

Phase 4
Completed
Conditions
Rotavirus Gastroenteritis
Interventions
Biological: Rotateq vaccine
Registration Number
NCT00740935
Lead Sponsor
University Hospital, Brest
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
7204
Inclusion Criteria
  • infants aged 6 to 12 weeks
  • born in Brest District, France
  • born between Feb 01, 2007 and Nov 19, 2009
Exclusion Criteria
  • contraindication to rotavirus vaccine

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Rotateq vaccineCohort of vaccinated infants against rotavirus
Primary Outcome Measures
NameTimeMethod
Hospitalization for gastroenteritis2 years
Secondary Outcome Measures
NameTimeMethod
Emergency department consultation for gastroenteritis2 years

Trial Locations

Locations (1)

Clinical Investigation Center

🇫🇷

Brest, France

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