CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 374 enrolled
Drug / intervention
No intervention doneother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01467037
NCT01467037N/ACompleted

Vaccine Effectiveness of RV1 in a Naïve Population

In Brief

An observational study evaluating No intervention done for Rotavirus Infections and 2 related conditions. Completed, enrolled 374 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2011
Enrollment StartFeb 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.7 years ago

Interventions

No intervention doneother

Not applicable because no intervention was done.