Vaccine Effectiveness of RV1 in a Naïve Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vaccine Effectiveness of RV1 in a Naïve Population

Conditions
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Rotavirus Infections, Gastroenteritis, Diarrhea

Intervention / Treatment
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* Other: No intervention done


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotavirus-negative<br>Patients with a negative result for rotavirus via enzyme immunoassay (EIA). No intervention done. | Other: No intervention done<br>* Not applicable because no intervention was done.<br>|
| Rotavirus-positive<br>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<br>* Not applicable because no intervention was done.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotavirus, Gastroenteritis, Vaccination, Pediatrics