Vaccine Effectiveness of RV1 in a Naïve Population

NCT01467037 | Completed Results

• 1 other identifier: MCH-ID-11-01
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 3

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.

Conditions

Rotavirus Infections; Gastroenteritis; Diarrhea

Keywords

Rotavirus; Gastroenteritis; Vaccination; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Vaccine Effectiveness of RV1

  From February 1, 2012 to May 31, 2014

Study Arms (2)

Rotavirus-negative

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

Other: 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.

Other: No intervention done

Interventions

No intervention done OTHER

Not applicable because no intervention was done.

Rotavirus-negative; Rotavirus-positive

Eligibility Criteria

• Age: 8 Weeks - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Institut National en Santé Publique du Québec: collaborator
• Ministere de la Sante et des Services Sociaux: collaborator
• GlaxoSmithKline: collaborator

Study Sites (3)

The Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 26546262 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool sample

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis; Diarrhea

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Caroline Quach, Pediatric Infectious Diseases Consultant & Medical Microbiologist
• Organization: McGill University Health Centre

caroline.quach@mcgill.ca

514-934-1934

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCPC

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 8, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 19, 2016
• Results First Posted: January 29, 2016

Record last verified: 2016-03

Locations

CA (3)