Vaccine Effectiveness of RV1 in a Naïve Population

McGill University

Status: Completed

Conditions: Diarrhea; Rotavirus Infections; Gastroenteritis

Treatments: Other: No intervention done

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01467037

MCH-ID-11-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 374 patients

Sex: All

Ages: 8 weeks to 3 years old

Volunteers: No Healthy Volunteers

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)

Trial design

374 participants in 2 patient groups

Rotavirus-negative

Description:

Patients with a negative result for rotavirus via enzyme immunoassay (EIA). No intervention done.

Treatment:

Other: No intervention done

Rotavirus-positive

Description:

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.

Treatment:

Other: No intervention done