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| Name | Class |
|---|---|
| Institut National en Santé Publique du Québec | OTHER |
| Ministere de la Sante et des Services Sociaux | OTHER |
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotavirus-negative | Patients with a negative result for rotavirus via enzyme immunoassay (EIA). 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention done | Other | Not applicable because no intervention was done. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From February 1, 2012 to May 31, 2014 |
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| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Effectiveness of RV1 | 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. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. RV1 VE was estimated as (1 - exposure odds ratio) × 100. Based upon our sampling scheme, the exposure odds ratio from our analyses approximates the rate ratio. |
Inclusion Criteria:
Cases:
Controls:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Quach-Thanh, MD, MSc | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Caroline Quach-Thanh, MD, MSc | McGill University Health Centre/Research Institute of the McGill University Health Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada | ||
| Centre Hospitalier Universitaire Sainte-Justine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26546262 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine Effectiveness Study Population | Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Among all active surveillance eligible patients, patients were included if parent/legal guardian had provided informed consent, and if an adequate stool specimen was provided within 7 days of hospital presentation. Patients needed to be aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotavirus-negative | All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group. |
| BG001 | Rotavirus -Positive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Rotavirus vaccination history by rotavirus disease status among matched VE participants | Posted | Number | participants | From February 1, 2012 to May 31, 2014 |
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Adverse events were not collected. We did not administer any medication nor vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccine Effectiveness Study Population | Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Caroline Quach, Pediatric Infectious Diseases Consultant & Medical Microbiologist | McGill University Health Centre | 514-934-1934 | 24485 | caroline.quach@mcgill.ca |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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stool sample
| From February 1, 2012 to May 31, 2014 |
| Montreal |
| Quebec |
| H3T 1C5 |
| Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
All stool were initially tested for rotavirus via enzyme immunoassay. 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.
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Rotavirus vaccination | Number | participants |
|
All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group. |
| OG001 | Rotavirus-positive | All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus positives were confirmed via realtime reversetranscriptase polymerase chain reactions (RTPCR). RTPCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed. |
|
|
| Other Pre-specified | Vaccine Effectiveness of RV1 | 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. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. RV1 VE was estimated as (1 - exposure odds ratio) × 100. Based upon our sampling scheme, the exposure odds ratio from our analyses approximates the rate ratio. | Posted | Number | 95% Confidence Interval | adjusted VE | From February 1, 2012 to May 31, 2014 |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Adjusted OR |
| 0.075 |
| 2-Sided |
| 95 |
| 0.018 |
| 0.307 |
Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) *100 |
| No |
| Superiority or Other |