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

NCT ID: NCT00740935

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rotavirus Gastroenteritis

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Cohort of vaccinated infants against rotavirus

Group Type OTHER

Rotateq vaccine

Intervention Type BIOLOGICAL

Vaccination against rotavirus

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

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Rotateq

Eligibility Criteria

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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
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MCM Vaccines B.V.

INDUSTRY

Sponsor Role collaborator

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud GAGNEUR, Doctor

Role: STUDY_DIRECTOR

University Hospital, Brest

Locations

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Clinical Investigation Center

Brest, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25080553 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21443962 (View on PubMed)

Other Identifiers

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RB 06.117

Identifier Type: -

Identifier Source: org_study_id