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NCT00740935 Clinical Trial

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

Rotavirus Gastroenteritis Clinical Trial

— IVANHOE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00740935
Other study ID # RB 06.117
Secondary ID
Status Completed
Phase Phase 4
First received August 22, 2008
Last updated October 18, 2013
Start date May 2007
Est. completion date June 2011

Study information
Verified date June 2012
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7204
Est. completion date June 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 6 Weeks to 12 Weeks
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France Clinical Investigation Center Brest

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Brest Sanofi Pasteur MSD

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalization for gastroenteritis 2 years No
Secondary Emergency department consultation for gastroenteritis 2 years No
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