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

November 4, 2011
July 28, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
ED visit or admission for RV+ sample [ Time Frame: Within 7 days of symptoms ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01467037 on ClinicalTrials.gov Archive Site
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Vaccine Effectiveness of RV1 in a Naïve Population
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 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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

stool sample

Non-Probability Sample

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.

  • Rotavirus Infections
  • Gastroenteritis
  • Diarrhea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1320
August 2016
December 2014   (final data collection date for primary outcome measure)

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)
Both
8 Weeks to 3 Years
No
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
Canada
 
NCT01467037
MCH-ID-11-01
No
Caroline Quach-Thanh, McGill University Health Center
McGill University Health Center
  • Institut National en Santé Publique du Québec
  • Ministere de la Sante et des Services Sociaux
  • GlaxoSmithKline
Principal Investigator: Caroline Quach-Thanh, MD, MSc McGill University Health Center
Study Director: Caroline Quach-Thanh, MD, MSc McGill University Health Center
McGill University Health Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP