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

Primary Purpose

Rotavirus Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Rotateq vaccine
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis focused on measuring prevention, rotavirus vaccine, gastroenteritis, systematic vaccination, infants, aged 6 to 12 weeks

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Investigation Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Cohort of vaccinated infants against rotavirus

Outcomes

Primary Outcome Measures

Hospitalization for gastroenteritis

Secondary Outcome Measures

Emergency department consultation for gastroenteritis

Full Information

First Posted
August 22, 2008
Last Updated
October 18, 2013
Sponsor
University Hospital, Brest
Collaborators
MCM Vaccines B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00740935
Brief Title
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
Acronym
IVANHOE
Official Title
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
MCM Vaccines B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Gastroenteritis
Keywords
prevention, rotavirus vaccine, gastroenteritis, systematic vaccination, infants, aged 6 to 12 weeks

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Cohort of vaccinated infants against rotavirus
Intervention Type
Biological
Intervention Name(s)
Rotateq vaccine
Other Intervention Name(s)
Rotateq
Intervention Description
Vaccination against rotavirus Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose.
Primary Outcome Measure Information:
Title
Hospitalization for gastroenteritis
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Emergency department consultation for gastroenteritis
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud GAGNEUR, Doctor
Organizational Affiliation
University Hospital, Brest
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigation Center
City
Brest
ZIP/Postal Code
29200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25080553
Citation
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.
Results Reference
derived
PubMed Identifier
21443962
Citation
Gagneur 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.
Results Reference
derived

Learn more about this trial

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

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