Rotavirus InfectionsNCT01467037
Vaccine Effectiveness of RV1 in a Naïve Population
An observational study of Rotavirus Infections and Gastroenteritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
Trial summary
Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would amount to 13,600 Canadian children < 5 years. Read more about this study
- Who is it for?
- Ages 8 weeks to 3 years
- Conditions the study is for
- Rotavirus Infections, Gastroenteritis, Diarrhea
- How many people
- 374 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2012to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 weeks to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: The Montreal Children's Hospital and the CHU Sainte-Justine are the 2 main pediatric hospitals in Montreal. With these 3 sites, 30% of the Quebec birth cohort will be captured and, given the concentration of children in the Montreal area, the participating hospitals will ensure that the study remains efficient in terms of resources. We elected Sherbrooke as an intermediate area; Montreal will represent an urban population.
Who may be able to join
- Child less than 3 years old
- Cases:
- Acute gastroenteritis (within 7 days of hospital visit)
- able to provide a stool specimen for RV ELISA testing
- Rotavirus positive
- Controls:
- Visited the ED or admitted for a non-rotavirus gastroenteritis
- Visited the ED or admitted for acute respiratory infections without gastroenteritis symptoms
Who cannot join
- Immunocompromised children
- Prior history of intussusception
- Admission to NICU between 6 to 15 weeks of life, for >6 weeks
- Child less than 56 days of life (8 weeks)
- Child vaccinated with Rotateq (Merck)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would amount to 13,600 Canadian children < 5 years. The incidence of nosocomial RV infections is an average of 8/10,000 patient-days in children < 5 years. An immunization program with a live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented, free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait of the disease and give critical information to the public health agencies as they struggle to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases with similar characteristics; estimate selection bias in passive laboratory-based surveillance; and estimate the agreement between surveillance time-series created from passive and active surveillance data sources.
Read the detailed description
In November 2011, Quebec implemented a publicly-funded RV1 vaccination program with its routine administration at 2 and 4 months of age. From February 1, 2012 - May 31, 2014, we conducted prospective, active surveillance for acute rotavirus gastroenteritis at The Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke. Active surveillance was approved by Research Ethics Boards at each hospital.
- Conditions
- Rotavirus Infections, Gastroenteritis, Diarrhea
- Being tested
- No intervention done
- Keywords
- Rotavirus, Gastroenteritis, Vaccination, Pediatrics
- Medical subject headings
- Rotavirus Infections, Gastroenteritis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention doneOther
Not applicable because no intervention was done.
| Study group | Role | What they receive |
|---|---|---|
| Rotavirus-negative | Patients with a negative result for rotavirus via enzyme immunoassay (EIA). No intervention done. Receives: Other: No intervention done | |
| Rotavirus-positive | Patients with a positive result for rotavirus via enzyme immunoassay (EIA). Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed. No intervention done. Receives: Other: No intervention done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matched VE Participants
RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.
We estimated RV1 VE of 2- versus 0-doses and ≥1- versus 0-doseto prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. Children vaccinated with RV5 (private market,minimal penetrance) were excluded.
Measured: From February 1, 2012 to May 31, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National en Santé Publique du Québec, Ministere de la Sante et des Services Sociaux, GlaxoSmithKline
- Responsible party
- Principal investigator, Caroline Quach-Thanh, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Caroline Quach-Thanh, MD, MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreCaroline Quach-Thanh, MD, MSc, Study director, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467037
- Sponsor's protocol ID
- MCH-ID-11-01
- Status last verified
- Mar 2016
- First submitted
- 4 Nov 2011
- Last updated
- 19 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Doll MK, Buckeridge DL, Morrison KT, Gagneur A, Tapiero B, Charest H, Quach C. Effectiveness of monovalent rotavirus vaccine in a high-income, predominant-use setting. Vaccine. 2015 Dec 16;33(51):7307-7314. doi: 10.1016/j.vaccine.2015.10.118. Epub 2015 Nov 3.
PubMed 26546262
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Effectiveness of RV1 in a Naïve Population
- ClinicalTrials.gov ID
- NCT01467037
- Acronym / sponsor ID
- MCH-ID-11-01
- Conditions
- Rotavirus Infections, Gastroenteritis, Diarrhea
- Keywords
- Rotavirus, Gastroenteritis, Vaccination, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Institut National en Santé Publique du Québec, Ministere de la Sante et des Services Sociaux, GlaxoSmithKline
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Posted 29 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would amount to 13,600 Canadian children < 5 years. The incidence of nosocomial RV infections is an average of 8/10,000 patient-days in children < 5 years. An immunization program with a live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented, free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait of the disease and give critical information to the public health agencies as they struggle to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases with similar characteristics; estimate selection bias in passive laboratory-based surveillance; and estimate the agreement between surveillance time-series created from passive and active surveillance data sources.
Detailed description
In November 2011, Quebec implemented a publicly-funded RV1 vaccination program with its routine administration at 2 and 4 months of age. From February 1, 2012 - May 31, 2014, we conducted prospective, active surveillance for acute rotavirus gastroenteritis at The Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke. Active surveillance was approved by Research Ethics Boards at each hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotavirus-negative | – | Other: No intervention donePatients with a negative result for rotavirus via enzyme immunoassay (EIA). No intervention done. |
| Rotavirus-positive | – | Other: No intervention donePatients with a positive result for rotavirus via enzyme immunoassay (EIA). Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed. No intervention done. |
Who may qualify
- Ages
- 8 weeks to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The Montreal Children's Hospital and the CHU Sainte-Justine are the 2 main pediatric hospitals in Montreal. With these 3 sites, 30% of the Quebec birth cohort will be captured and, given the concentration of children in the Montreal area, the participating hospitals will ensure that the study remains efficient in terms of resources. We elected Sherbrooke as an intermediate area; Montreal will represent an urban population.
Key inclusion criteria (8 listed)
- Child less than 3 years old
- Acute gastroenteritis (within 7 days of hospital visit)
- able to provide a stool specimen for RV ELISA testing
- Rotavirus positive
- Visited the ED or admitted for a non-rotavirus gastroenteritis
Key exclusion criteria (5 listed)
- Immunocompromised children
- Prior history of intussusception
- Admission to NICU between 6 to 15 weeks of life, for >6 weeks
- Child less than 56 days of life (8 weeks)
- Child vaccinated with Rotateq (Merck)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention doneNot applicable because no intervention was done. | Other | Rotavirus-negative, Rotavirus-positive |
Primary outcome
Matched VE Participants
Time frame: From February 1, 2012 to May 31, 2014
RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively. We estimated RV1 VE of 2- versus 0-doses and ≥1- versus 0-doseto prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. Children vaccinated with RV5 (private market,minimal penetrance) were excluded.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26546262Doll MK, Buckeridge DL, Morrison KT, Gagneur A, Tapiero B, Charest H, Quach C. Effectiveness of monovalent rotavirus vaccine in a high-income, predominant-use setting. Vaccine. 2015 Dec 16;33(51):7307-7314. doi: 10.1016/j.vaccine.2015.10.118. Epub 2015 Nov 3.
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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.
Caroline Quach-Thanh, MD, MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Caroline Quach-Thanh, MD, MSc study director
McGill University Health Centre/Research Institute of the McGill University Health Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Infections and Gastroenteritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites 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 8 inclusion and 5 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Matched VE Participants (time frame: From February 1, 2012 to May 31, 2014). 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 NCT01467037, which also lists 1 linked publication.
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 19 Apr 2016.