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

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 4

Conditions: Rotavirus Gastroenteritis

Treatments: Biological: Rotateq vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00740935

RB 06.117

Details and patient eligibility

About

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.

Enrollment: 7,204 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7,204 participants in 1 patient group

1

Other group

Description:

Cohort of vaccinated infants against rotavirus

Treatment:

Biological: Rotateq vaccine