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

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur MSD
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00740935
First received: August 22, 2008
Last updated: February 20, 2012
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Rotavirus Gastroenteritis
 Biological: Rotateq vaccine
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Hospitalization for gastroenteritis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Emergency department consultation for gastroenteritis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 7204
Study Start Date: May 2007
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Cohort of vaccinated infants against rotavirus
 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.

Other Name: Rotateq

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740935

Locations
France
Clinical Investigation Center
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest
Sanofi Pasteur MSD
Investigators
Study Director: Arnaud GAGNEUR, Doctor University Hospital, Brest
  More Information

No publications provided by University Hospital, Brest

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT00740935     History of Changes
Other Study ID Numbers: RB 06.117
Study First Received: August 22, 2008
Last Updated: February 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
prevention
rotavirus vaccine
gastroenteritis
 systematic vaccination
infants
aged 6 to 12 weeks

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013