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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:
ClinicalTrials.gov Identifier:
NCT00740935
First Posted: August 25, 2008
Last Update Posted: October 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MCM Vaccines B.V.
Information provided by (Responsible Party):
University Hospital, Brest
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Hospitalization for gastroenteritis [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Emergency department consultation for gastroenteritis [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740935


Locations
France
Clinical Investigation Center
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest
MCM Vaccines B.V.
Investigators
Study Director: Arnaud GAGNEUR, Doctor University Hospital, Brest
  More Information

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
First Submitted: August 22, 2008
First Posted: August 25, 2008
Last Update Posted: October 22, 2013
Last Verified: June 2012

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs