Evaluation of Universal Rotavirus Vaccination Program

NCT01273077 | Completed

• 2 other identifiers: GS1001REB 4997
• Study Type: observational
• Target: 12,705
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases

Keywords

Rotavirus; Rotarix

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of Rotarix as detected through reduction of burden of illness due to rotavirus gastroenteritis

  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 Outcomes (1)

• To evaluate the implementation of a universal infant rotavirus immunization program with Rotarix

  2 years

Study Arms (6)

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.

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• Non-laboratory confirmed diagnosis.
• Cases which do not have clinical data accessible by the nurse monitors
• Prospective surveillance
• 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:

Sponsors & Collaborators

• Dalhousie University: lead
• IWK Health Centre: collaborator
• University of Prince Edward Island: collaborator
• Horizon Health Care New Brunswick: collaborator
• GlaxoSmithKline: collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Canadian Center for Vaccinology, IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (3)

• Zelman M, Sanford C, Neatby A, Halperin BA, MacDougall D, Rowswell C, Langley JM, Halperin SA; Maritime Universal Rotavirus Vaccination Program (MURVP). Implementation of a universal rotavirus vaccination program: comparison of two delivery systems. BMC Public Health. 2014 Sep 2;14:908. doi: 10.1186/1471-2458-14-908.

  PMID: 25182067 RESULT

• Sanford C, Langley JM, Halperin SA, Zelman M, Mvrvp. A universal infant rotavirus vaccine program in two delivery models: Effectiveness and adverse events following immunization. Hum Vaccin Immunother. 2015;11(4):870-4. doi: 10.1080/21645515.2015.1012028.

  PMID: 25746110 RESULT

• MacDougall DM, Halperin BA, Langley JM, MacKinnon-Cameron D, Li L, Halperin SA; Maritime Universal Rotavirus Vaccination Program (MURVP). Knowledge, attitudes, beliefs, and behaviors of parents and healthcare providers before and after implementation of a universal rotavirus vaccination program. Vaccine. 2016 Jan 27;34(5):687-695. doi: 10.1016/j.vaccine.2015.09.089. Epub 2015 Oct 14.

  PMID: 26458809 DERIVED

Related Links

• Canadian Center for Vaccinology
• BMC Public Health.2014, 14:908

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Donna MacDougall, PhD, RN

  Canadian Center for Vaccinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Scott Halperin

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: December 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

CA (1)