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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00740935
Acronym
IVANHOE
Enrollment
7204
Registered
2008-08-25
Start date
2007-05-31
Completion date
2011-06-30
Last updated
2013-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotavirus Gastroenteritis

Keywords

prevention, rotavirus vaccine, gastroenteritis, systematic vaccination, infants, aged 6 to 12 weeks

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.

Interventions

BIOLOGICALRotateq vaccine

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

Sponsors

MCM Vaccines B.V.
CollaboratorINDUSTRY
University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hospitalization for gastroenteritis2 years

Secondary

MeasureTime frame
Emergency department consultation for gastroenteritis2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026