Evaluation of Universal Rotavirus Vaccination Program

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01273077

Enrollment

12705

Registered

2011-01-10

Start date

2010-12-31

Completion date

2013-07-31

Last updated

2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Diseases

Keywords

Rotavirus, Rotarix

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to No maximum

Healthy volunteers

Yes

Inclusion criteria

Rotarix immunization Program: Inclusion criteria: All infants in Nova Scotia DHA 9 and PEI born between October 1, 2010 and September 30, 2012. 6 weeks to 6 months of age at time of vaccination. Exclusion: * Infants who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. * Infants who experienced hypersensitivity after previous administration of rotavirus vaccines. * Infants with uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception. Retrospective Surveillance (2008-2010) Inclusion criteria: * Confirmed rotavirus case in stool specimen taken within 14 days after the onset of gastrointestinal symptoms. Cases identified by autopsy must have had gastrointestinal symptoms before death. * Rotavirus identified during 2008-2010 * Children less than 2 years of age * Inpatient at site hospital * Any patient who has a documented rotavirus hospital acquired infection * Referred confirmed cases from another institution.

Exclusion criteria

* Non-laboratory confirmed diagnosis. * Cases which do not have clinical data accessible by the nurse monitors Prospective surveillance Inclusion/

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the effectiveness of Rotarix as detected through reduction of burden of illness due to rotavirus gastroenteritis	2 years	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.

Secondary

Measure	Time frame	Description
To evaluate the implementation of a universal infant rotavirus immunization program with Rotarix	2 years	We do not have a hypothesis for the second primary objective as it is a descriptive analysis of program implementation.

Countries

Canada

Outcome results