Evaluation of Universal Rotavirus Vaccination Program
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Evaluation of Universal Rotavirus Vaccination Program|
- To evaluate the effectiveness of Rotarix as detected through reduction of burden of illness due to rotavirus gastroenteritis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Our hypothesis for the first primary objective is that implementation of a universal rotavirus immunization program will result in a decreased burden of disease, as defined by number of hospitalizations in infants under one year of age, due to rotavirus. Evaluation of this objective will consist of the collection and comparison of retrospective and prospective surveillance data.
- To evaluate the implementation of a universal infant rotavirus immunization program with Rotarix [ Time Frame: 2 years ] [ Designated as safety issue: No ]We do not have a hypothesis for the second primary objective as it is a descriptive analysis of program implementation.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Evaluation of Rotarix Program
All infants in Nova Scotia DHA 9 and PEI born after October1, 2010 until September 31, 2012 will be eligible for Rotarix immunization as part of the publicly funded immunization program. New Brunswick will serve as the non-intervention control location.
All laboratory- confirmed cases of rotavirus gastroenteritis and all cause diarrhea admitted to the trial hospitals from 2008-2010 will be entered in the database.
Will begin on December 1, 2010. Data will be collected to identify hospitalizations for all cause diarrhea and rotavirus gastroenteritis at all 3 sites through the first two consecutive rotavirus seasons following vaccination.
Each trial hospital will identify cases of severe diarrhea and intussusception in Rotarix vaccine recipients through the first two consecutive rotavirus seasons following vaccination.
ED Rotavirus Snap Shot Study
During rotavirus peak season, a prospective study of a sample of children under the age of 2 years presenting with diarrhea with or without vomiting to the ER of participating trial centers will be conducted.
KAB Questionnaire for HCP and Parents
Data will be collected by a validated survey given to Parents, Healthcare providers and Program organizers throughout the 2 year program.
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:
- To evaluate vaccine efficacy against rotavirus gastroenteritis of any severity in children under one year of age following 2 oral doses of Rotarix
- To evaluate the burden of illness (hospitalization) associated with rotavirus infection in children less than 12 months of age.
- To monitor the incidence of severe side effects associated with uptake of Rotarix vaccine in program participants.
- 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:
- To examine and compare the effectiveness of two program delivery systems (physician administered and public health administered) in providing the rotavirus vaccination to infants.
- To evaluate the logistics of program implementation using the Rotarix vaccine in a cohort of infants.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273077
|Contact: Donna MacDougall, PhD RNfirstname.lastname@example.org|
|Contact: Pamela Publicover-Brouwer, RNemail@example.com|
|Canada, Nova Scotia|
|Canadian Center for Vaccinology, IWK Health Centre||Recruiting|
|Halifax, Nova Scotia, Canada|
|Contact: Scott Halperin, MD 902-470-8141 firstname.lastname@example.org|
|Contact: Donna MacDougall, PhD RN 902-867-5392 email@example.com|
|Sub-Investigator: Scott Halperin, MD|
|Sub-Investigator: Beth Halperin, MN RN|
|Sub-Investigator: Joanne Langley, MD|
|Sub-Investigator: Shelly McNeil, MD|
|Sub-Investigator: Gaynor Watson-Creed, MD|
|Sub-Investigator: LaMont Sweet, MD|
|Sub-Investigator: Mitch Zelman, MD|
|Sub-Investigator: Scott Giffin, MD|
|Sub-Investigator: Marc Nicholson, MD|
|Principal Investigator:||Donna MacDougall, PhD, RN||Canadian Center for Vaccinology|