Vaccine Effectiveness of RV1 in a Naïve Population
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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 |
- 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: | February 2014 |
| Estimated Primary Completion Date: | January 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 |
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.
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| 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, 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 | Recruiting |
| Montréal, Quebec, Canada, H3T 1C5 | |
| Contact: Bruce Tapiero, MD 514-345-4931 ext 5566 Bruce_Tapiero@SSSS.gouv.qc.ca | |
| Contact: Christian Renaud, MD, MSc 514-345-4931 christian.renaud.hsj@ssss.gouv.qc.ca | |
| Sub-Investigator: Christian Renaud, MD, MSc | |
| Principal Investigator: Bruce Tapiero, MD | |
| 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 | |
| Principal Investigator: | Caroline Quach-Thanh, MD, MSc | McGill University Health Center |
| Principal Investigator: | David L Buckeridge, MD, PhD | McGill University |
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: | December 20, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McGill University Health Center:
|
Rotavirus Gastroenteritis Vaccination Pediatrics |
Additional relevant MeSH terms:
|
Diarrhea Gastroenteritis Rotavirus Infections Signs and Symptoms, Digestive Signs and Symptoms |
Gastrointestinal Diseases Digestive System Diseases Reoviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013