Clinical trial NCT01467037: Vaccine Effectiveness of RV1 in a Naïve Population
Official title: Vaccine Effectiveness of RV1 in a Naïve Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus Infections
Gastroenteritis
Diarrhea
Keywords: Rotavirus
Gastroenteritis
Vaccination
Pediatrics
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Institut National en Santé Publique du Québec
name: Ministere de la Sante et des Services Sociaux
name: GlaxoSmithKline
First posted: 2011-11-08
Enrollment: 374
Sex: ALL
Minimum age (years): 8
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Matched VE Participants
timeFrame: From February 1, 2012 to May 31, 2014
Secondary outcomes:
Other outcomes:
measure: Vaccine Effectiveness of RV1
timeFrame: From February 1, 2012 to May 31, 2014
Locations:
city: Montreal
country: Canada
facility: The Montreal Children's Hospital
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Caroline Quach-Thanh, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Caroline Quach-Thanh, MD, MSc
role: STUDY_DIRECTOR
References:
citation: 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.