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Trial record 1 of 1 for:    01273077
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Evaluation of Universal Rotavirus Vaccination Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01273077
Recruitment Status : Unknown
Verified January 2011 by Dalhousie University.
Recruitment status was:  Recruiting
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
IWK Health Centre
University of Prince Edward Island
Horizon Health Care New Brunswick
Nova Scotia Health Authority
Information provided by:
Dalhousie University

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.

Condition or disease
Gastrointestinal Diseases

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 year 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 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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Universal Rotavirus Vaccination Program
Study Start Date : December 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : March 2013

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.
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.
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All infants in Nova Scotia DHA 9 and PEI born after October 1, 2010 until September 31, 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 2010-2012 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 2012 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.


Rotarix immunization Program:

Inclusion criteria:

All infants in Nova Scotia DHA 9 and PEI born after October 1, 2010 until September 31, 2012. 6 weeks to 6 months of age at time of vaccination.


  • 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, 2012.

Safety monitoring Intussusception Surveillance:

Inclusion criteria:

  • 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.

Emergency Department Rotavirus Snap Shot Study

Inclusion criteria:

  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01273077

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Contact: Donna MacDougall, PhD RN 902-470-8141
Contact: Pamela Publicover-Brouwer, RN 902-470-3921

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Canada, Nova Scotia
Canadian Center for Vaccinology, IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada
Contact: Scott Halperin, MD    902-470-8141   
Contact: Donna MacDougall, PhD RN    902-867-5392   
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         
Sponsors and Collaborators
Dalhousie University
IWK Health Centre
University of Prince Edward Island
Horizon Health Care New Brunswick
Nova Scotia Health Authority
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Principal Investigator: Donna MacDougall, PhD, RN Canadian Center for Vaccinology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Donna MacDougall, Canadian Center for Vaccinology Identifier: NCT01273077    
Obsolete Identifiers: NCT01401686
Other Study ID Numbers: GS1001
REB 4997 ( Other Grant/Funding Number: GlaxoSmithKline )
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011
Keywords provided by Dalhousie University:
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases