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Trial record 3 of 8 for:    Open Studies | "Rotavirus Infections"

Vaccine Effectiveness of RV1 in a Naïve Population

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by McGill University Health Center
Sponsor:
Collaborators:
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
GlaxoSmithKline
Information provided by (Responsible Party):
Caroline Quach-Thanh, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01467037
First received: November 4, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Canadian children < 5 years. The incidence of nosocomial RV infections is an average of 8/10,000 patient-days in children < 5 years. An immunization program with a live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented, free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait of the disease and give critical information to the public health agencies as they struggle to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases with similar characteristics; estimate selection bias in passive laboratory-based surveillance; and estimate the agreement between surveillance time-series created from passive and active surveillance data sources.


Condition
Rotavirus Infections
Gastroenteritis
Diarrhea

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vaccine Effectiveness of RV1 in a Naïve Population

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • ED visit or admission for RV+ sample [ Time Frame: Within 7 days of symptoms ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

stool sample


Estimated Enrollment: 1320
Study Start Date: February 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   8 Weeks to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The Montreal Children's Hospital and the CHU Sainte-Justine are the 2 main pediatric hospitals in Montreal. With these 3 sites, 30% of the Quebec birth cohort will be captured and, given the concentration of children in the Montreal area, the participating hospitals will ensure that the study remains efficient in terms of resources. We elected Sherbrooke as an intermediate area; Montreal will represent an urban population.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467037

Contacts
Contact: Caroline Quach-Thanh, MD, MSc 514-934-1934 ext 22620 caroline.quach@mcgill.ca
Contact: Deirdre McCormack, BScN, CCRC 514-934-1934 ext 22832 deirdre.mccormack@muhc.mcgill.ca

Locations
Canada, Quebec
The Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Caroline Quach-Thanh, MD, MSc    514-934-1934 ext 22620    caroline.quach@mcgill.ca   
Contact: Deirdre McCormack, BScN, CCRC    514-934-1934 ext 22832    deirdre.mccormack@muhc.mcgill.ca   
Principal Investigator: Caroline Quach-Thanh, MD, MSc         
Centre Hospitalier Universitaire Sainte-Justine Completed
Montréal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Arnaud Gagneur, MD, PhD    819-346-1110 ext 14634    arnaud.gagneur@usherbrooke.ca   
Principal Investigator: Arnaud Gagneur, MD, PhD         
Sponsors and Collaborators
McGill University Health Center
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
GlaxoSmithKline
Investigators
Principal Investigator: Caroline Quach-Thanh, MD, MSc McGill University Health Center
Study Director: Caroline Quach-Thanh, MD, MSc McGill University Health Center
  More Information

No publications provided

Responsible Party: Caroline Quach-Thanh, MD, MSc, FRCPC, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01467037     History of Changes
Other Study ID Numbers: MCH-ID-11-01
Study First Received: November 4, 2011
Last Updated: July 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Rotavirus
Gastroenteritis
Vaccination
Pediatrics

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Digestive System Diseases
Gastrointestinal Diseases
RNA Virus Infections
Reoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014