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Vaccine Effectiveness of RV1 in a Naïve Population

NCT01467037 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 374

Last updated 2016-04-19

Study results available
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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.

Conditions

Interventions

OTHER

No intervention done

Not applicable because no intervention was done.

Sponsors & Collaborators

  • Institut National en Santé Publique du Québec

    collaborator OTHER

  • Ministere de la Sante et des Services Sociaux

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Caroline Quach-Thanh, MD, MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Caroline Quach-Thanh, MD, MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
8 Weeks
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01467037 on ClinicalTrials.gov