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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotavirus Gastroenteritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Investigation Center

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotateq vaccine

Biological

Vaccination against rotavirus

Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose.

Other names: Rotateq

Primary outcomes

Hospitalization for gastroenteritis

Time frame: 2 years

Secondary outcomes

Emergency department consultation for gastroenteritis

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

MCM Vaccines B.V.

Registry information

Acronym: IVANHOE

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2011
First posted: Aug 25, 2008
Registry last updated: Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed