Evaluation of Universal Rotavirus Vaccination Program

Study Overview
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Brief Summary
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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
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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 - three year(s) 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 - 3 years 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.

Official Title
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Evaluation of Universal Rotavirus Vaccination Program

Conditions
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Gastrointestinal Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Evaluation of Rotarix Program<br>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<br>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<br>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<br>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<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotavirus, Rotarix