Evaluation of Universal Rotavirus Vaccination Program

January 19, 2022 updated by: Scott Halperin, Dalhousie University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12705

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Canadian Center for Vaccinology, IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants in Nova Scotia DHA 9 and PEI born after October 1, 2010 until September 30, 2012 will be eligible for Rotarix immunization. Infants must be 6 weeks to 6 months of age at time of vaccination.

All confirmed hospitalized Rotavirus cases from 2008-2010 and 2010-2013 will be entered in a database.

All Intussusception cases after program start.

Small sample size of outpatient confirmed rotavirus cases during rotavirus peak season 2011 and 2013 will be studied.

Parents of infants eligible to receive Rotarix during the program will be invited to complete a KAB survey during the program as well as all healthcare providers eligible to administer Rotarix vaccine. Program organizers will be invited to take part in key informant interviews at the end of the program.

Description

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/Exclusion criteria:

Same as listed above for retrospective surveillance except the time period of surveillance will be December 1, 2010 - November 30, 2013.

Safety monitoring Intussusception Surveillance:

Inclusion criteria: Year 1 and 2

  • Children less than 2 years of age presenting to the study site hospital (inpatients and outpatients)

  • Radiologic or surgical diagnosis of intussusception and based on the Level 1 Brighton criteria:

    1.Invagination of the intestine (intussusception) demonstrated at surgery /2 demonstrated using air or liquid contrast enema 3.An intra-abdominal mass demonstrated using ultrasound or CT scan and was proven to be reduced by hydrostatic enema on a post-reduction imaging 4.Invagination of the intestine (intussusception) demonstrated at autopsy

  • Presentation to hospital from December 1, 2010 - November 30. 2012

Exclusion criteria:

  • Children 2 years of age or older

  • Children with intussusception which is a direct complication of a surgical procedure.

    • Year 3 will include children less than 3 years of age

Emergency Department Rotavirus Snap Shot Study

Inclusion criteria: Year 1

  • All children less than 2 years-old presenting with gastroenteritis who have a positive confirmed test for rotavirus, stool specimen taken within 14 days after the onset of symptoms.
  • Telephone informed consent obtained from the parent or legal guardian.
  • Parent or legal guardian can read and write English and can understand the informed consent documents and the study instructions and are mentally competent to give consent.

Exclusion Criteria:

  • No stool sample
  • Authorization not obtained

In year 2 and 3 of the project:, systematic stool sampling will be carried out for cases of gastroenteritis in children < 5 years of age presenting to the ED departments.

KAB Questionnaire for Health Care Providers and Parents

Inclusion criteria:

  • Parents of healthy newborns eligible for the Rotarix vaccination program
  • Parents who have a good understanding of English.
  • Providers who were registered with the College of Registered Nurses of Nova Scotia, the Association of Registered Nurses of Prince Edward Island, the Nurses Association of New Brunswick, the Nova Scotia College of Family Physicians, the Prince Edward Island College of Family Physicians, or the New Brunswick College of Family Physicians for at least one year.
  • Program managers responsible for immunization programs in PEI and NS DHA 9

Exclusion Criteria:

•Parents of newborns with a debilitating disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Evaluation of Rotarix Program
All infants in Nova Scotia DHA 9 and PEI born after October1, 2010 until September 30, 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.
Retrospective Surveillance
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.
Prospective Surveillance
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.
Safety Intussusception
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 in year one. In year 2 and 3 of the project:, systematic stool sampling will be carried out for cases of gastroenteritis in children < 5 years of age presenting to the ED departments.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the effectiveness of Rotarix as detected through reduction of burden of illness due to rotavirus gastroenteritis
Time Frame: 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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the implementation of a universal infant rotavirus immunization program with Rotarix
Time Frame: 2 years
We do not have a hypothesis for the second primary objective as it is a descriptive analysis of program implementation.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dalhousie University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline
Nova Scotia Health Authority
IWK Health Centre
University of Prince Edward Island
Horizon Health Care New Brunswick

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donna MacDougall, PhD, RN, Canadian Center for Vaccinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS1001
  • REB 4997 (Other Grant/Funding Number: GlaxoSmithKline)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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