An observational study in Rotavirus Infections, Gastroenteritis and Diarrhea, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 3 sites in Canada. Open to participants aged 8 Weeks to 3 Years. Per ClinicalTrials.gov, last updated 2016-04-19.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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.
101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 374 is below the median of 885 across 31 observational studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 415 studies on the registry; 106 are open to participants now.
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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.
Cases:
Controls:
Exclusion Criteria:
Patients with a negative result for rotavirus via enzyme immunoassay (EIA). No intervention done.
Other: No intervention done
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.
Other: No intervention done
Not applicable because no intervention was done.
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.
Time frame: From February 1, 2012 to May 31, 2014
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.
Time frame: From February 1, 2012 to 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.
| Milestone | Vaccine Effectiveness Study Population |
|---|---|
| Started | 374 |
| Completed | 374 |
| Not completed | 0 |
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.
| participants | Rotavirus-negative | Rotavirus-positive |
|---|---|---|
| 0-Doses | 26 | 22 |
| 1 Dose | 16 | 1 |
| 2 Doses | 114 | 7 |
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.
| adjusted VE | 2 Versus 0 Doses | ≥1 Versus 0 Dose |
|---|---|---|
| Vaccine Effectiveness of RV1 | 91.2 (61.6 to 98.0) | 92.5 (69.3 to 98.2) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccine Effectiveness Study Population | — | — | — |
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.
| Age, Continuous(months) | Rotavirus-negative | Rotavirus -Positive | Total |
|---|---|---|---|
| Mean | 12.6 ± 6.3 | 16.6 ± 6.5 | 13 ± 6.4 |
| Sex: Female, Male(Participants) | Rotavirus-negative | Rotavirus -Positive | Total |
|---|---|---|---|
| Female | 154 | 20 | 174 |
| Male | 188 | 12 | 200 |
| Region of Enrollment(participants) | Rotavirus-negative | Rotavirus -Positive | Total |
|---|---|---|---|
| Canada | 342 | 32 | 374 |
| Rotavirus vaccination(participants) | Rotavirus-negative | Rotavirus -Positive | Total |
|---|---|---|---|
| RV-vaccination 0 dose | 62 | 24 | 86 |
| RV-vaccination 1-dose | 26 | 1 | 27 |
| RV-vaccination ≥2 doses | 254 | 7 | 261 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre