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COMPLETEDNCT01467037

Vaccine Effectiveness of RV1 in a Naïve Population

Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of \< 24 hours is 1/25, which would amount to 13,600...

Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre•3 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
GlaxoSmithKline

In November 2011, Quebec implemented a publicly-funded RV1 vaccination program with its routine administration at 2 and 4 months of age. From February 1, 2012 - May 31, 2014, we conducted prospective, active surveillance for acute rotavirus gastroenteritis at The Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke. Active surveillance was approved by Research Ethics Boards at each hospital.

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Child less than 3 years old
•Cases:
•Acute gastroenteritis (within 7 days of hospital visit)
•able to provide a stool specimen for RV ELISA testing
•Rotavirus positive
•Controls:
•Visited the ED or admitted for a non-rotavirus gastroenteritis
•Visited the ED or admitted for acute respiratory infections without gastroenteritis symptoms

Exclusion Criteria

•Immunocompromised children
•Prior history of intussusception
•Admission to NICU between 6 to 15 weeks of life, for \>6 weeks
•Child less than 56 days of life (8 weeks)
•Child vaccinated with Rotateq (Merck)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 19, 2016Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment374

Start dateFeb 2012

Last updatedApr 19, 2016

Condition

Rotavirus Infections Gastroenteritis Diarrhea

Locations shown

The Montreal Children's Hospital

Montreal, Quebec

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2016Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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