Status:
COMPLETED
Vaccine Effectiveness of RV1 in a Naïve Population
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
Conditions:
Rotavirus Infections
Gastroenteritis
Eligibility:
All Genders
8-3 years
Brief Summary
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...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT01467037
Start Date
February 1 2012
End Date
December 1 2014
Last Update
April 19 2016
Active Locations (3)
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1
The Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
2
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
3
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4