Vaccine Effectiveness of RV1 in a Naïve Population

Diarrhea Clinical Trial

Official title: Vaccine Effectiveness of RV1 in a Naïve Population

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diarrhea
• Gastroenteritis
• Rotavirus Infections

• NCT number: NCT01467037
• Study type: Observational
• Source: McGill University Health Center
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Completion date: December 2014