NCT01467037

Vaccine Effectiveness of RV1 in a Naïve Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 374 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 8 Weeks – 3 Years
• Healthy volunteers: Not accepted

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 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.

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, 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.

Conditions

• Rotavirus Infections
• Gastroenteritis
• Diarrhea

Interventions

Type	Name	Description
OTHER	No intervention done	Not applicable because no intervention was done.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-11-08
• Last updated: 2016-04-19
• Results posted: 2016-01-29

Locations

3 sites across 1 country: Canada