Gastrointestinal DiseasesNCT01273077
Evaluation of Universal Rotavirus Vaccination Program
An observational study of Gastrointestinal Diseases, run by Dalhousie University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases
- Type of treatment
- Vaccines
- How many people
- 12,705 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- 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
Show all 20Show fewer
- Referred confirmed cases from another institution.
- 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:
- 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
- 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.
- 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
Who cannot join
- 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)
- Non-laboratory confirmed diagnosis.
- Cases which do not have clinical data accessible by the nurse monitors
Show all 16Show fewer
- Prospective surveillance
- 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
- 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
- •Parents of newborns with a debilitating disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canadian Center for Vaccinology, IWK Health Centre
Halifax, Nova Scotia
About this study
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.
Read the 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:
- 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.
- Conditions
- Gastrointestinal Diseases
- Keywords
- Rotavirus, Rotarix
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Health Centre, University of Prince Edward Island, Horizon Health Care New Brunswick, GlaxoSmithKline, Nova Scotia Health Authority
- Responsible party
- Principal investigator, Scott Halperin, Dalhousie University
- Investigators
- Donna MacDougall, PhD, RN, Principal investigator, Canadian Center for Vaccinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273077
- Sponsor's protocol ID
- GS1001
- Other IDs
- REB 4997
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2011
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25182067Sanford 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.
PubMed 25746110MacDougall 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.
PubMed 26458809
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Universal Rotavirus Vaccination Program
- ClinicalTrials.gov ID
- NCT01273077
- Acronym / sponsor ID
- GS1001
- Conditions
- Gastrointestinal Diseases
- Keywords
- Rotavirus, Rotarix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,705 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- IWK Health Centre, University of Prince Edward Island, Horizon Health Care New Brunswick, GlaxoSmithKline, Nova Scotia Health Authority
- Study start
- Dec 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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.
- 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
Key exclusion criteria (16 listed)
- 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)
- Non-laboratory confirmed diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
To evaluate the implementation of a universal infant rotavirus immunization program with Rotarix
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Results publication: PubMed 25182067Zelman 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.
- Results publication: PubMed 25746110Sanford 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.
- Derived from this study: PubMed 26458809MacDougall 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.
- Canadian Center for VaccinologyLink provided by the sponsor.
- BMC Public Health.2014, 14:908Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna MacDougall, PhD, RN principal investigator
Canadian Center for Vaccinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases, run by Dalhousie University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of Rotarix as detected through reduction of burden of illness due to rotavirus gastroenteritis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01273077, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.