Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
IVANHOE
1 other identifier
interventional
7,204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedOctober 22, 2013
June 1, 2012
3.6 years
August 22, 2008
October 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization for gastroenteritis
2 years
Secondary Outcomes (1)
Emergency department consultation for gastroenteritis
2 years
Study Arms (1)
1
OTHERCohort of vaccinated infants against rotavirus
Interventions
Vaccination against rotavirus Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose.
Eligibility Criteria
You may qualify if:
- infants aged 6 to 12 weeks
- born in Brest District, France
- born between Feb 01, 2007 and Nov 19, 2009
You may not qualify if:
- contraindication to rotavirus vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Brestlead
- MCM Vaccines B.V.collaborator
Study Sites (1)
Clinical Investigation Center
Brest, 29200, France
Related Publications (2)
Roue JM, Nowak E, Le Gal G, Lemaitre T, Oger E, Poulhazan E, Giroux JD, Garenne A, Gagneur A. Impact of rotavirus vaccine on premature infants. Clin Vaccine Immunol. 2014 Oct;21(10):1404-9. doi: 10.1128/CVI.00265-14. Epub 2014 Jul 30.
PMID: 25080553DERIVEDGagneur A, Nowak E, Lemaitre T, Segura JF, Delaperriere N, Abalea L, Poulhazan E, Jossens A, Auzanneau L, Tran A, Payan C, Jay N, de Parscau L, Oger E; IVANHOE investigators. Impact of rotavirus vaccination on hospitalizations for rotavirus diarrhea: the IVANHOE study. Vaccine. 2011 May 12;29(21):3753-9. doi: 10.1016/j.vaccine.2011.03.035. Epub 2011 Apr 13.
PMID: 21443962DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arnaud GAGNEUR, Doctor
University Hospital, Brest
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 25, 2008
Study Start
May 1, 2007
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
October 22, 2013
Record last verified: 2012-06