Evaluation of Universal Rotavirus Vaccination Program

Gastrointestinal Diseases Clinical Trial

Official title: Evaluation of Universal Rotavirus Vaccination Program

Status Completed

Clinical Trial Summary

Two rotavirus vaccines have been authorized for use in Canada: RotaTeq®, Merck Frost Canada, Inc. and Rotarix®, Glaxo Smith Kline (GSK). In contrast to the United States, Australia and several other western countries, neither rotavirus vaccine is offered in a publicly funded program in Canada. A universal rotavirus immunization program offered to all children has the potential to prevent moderate to severe forms of the disease associated with rotavirus, with associated decreased disease burden and health care costs. This demonstration project seeks to evaluate the effect of the implementation of a universal infant immunization program with Rotarix employing two different program delivery models (public health delivery or physician office delivery) in comparison to a jurisdiction where routine immunization is not provided. Only evaluation of the program will be the subject of this study.

Clinical Trial Description

Rotavirus immunization will be provided as part of the routine, publicly provided immunization program in PEI through Public Health Clinics and in Nova Scotia District Health Authority (DHA) 9 through physicians' offices. Saint John, New Brunswick will act as the control site where no publicly funded immunizations with Rotarix are provided. There are four components to the demonstration project which will take place at each of the three sites: retrospective surveillance, prospective surveillance, a prospective Emergency Department study, and an overall evaluation of the program and its acceptability. Actual provision of the vaccine through a universal immunization program will be undertaken by public health in PEI and in NS DHA 9. The objectives of the rotavirus surveillance (retrospective/prospective) and prospective ED study are:

1. To evaluate vaccine efficacy against rotavirus gastroenteritis of any severity in children under one - three year(s) of age following 2 oral doses of Rotarix.

2. To evaluate the burden of illness (hospitalization) associated with rotavirus infection in children less than 12 months - 3 years of age.

3. To monitor the incidence of severe side effects associated with uptake of Rotarix vaccine in program participants.

4. To provide data that is required to estimate costs associated with managing rotavirus in a hospital setting and at home.

The objectives for the universal rotavirus immunization program evaluation are:

1. To examine and compare the effectiveness of two program delivery systems (physician administered and public health administered) in providing the rotavirus vaccination to infants.

2. To evaluate the logistics of program implementation using the Rotarix vaccine in a cohort of infants.

3. To evaluate the acceptability of a universal rotavirus vaccination program by parents, physicians and nurses by measuring parent, nurse, and physician Knowledge Attitudes and Beliefs about rotavirus gastroenteritis. ;

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

• NCT number: NCT01273077
• Study type: Observational
• Source: Dalhousie University
• Status: Completed
• Start date: December 2010
• Completion date: July 2013