Vaccine Effectiveness of RV1 in a Naïve Population

NCT ID: NCT01467037

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 374 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-12-31

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.

Conditions

Rotavirus Infections; Gastroenteritis; Diarrhea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Rotavirus-negative

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

No intervention done

Intervention Type: OTHER

Not applicable because no intervention was 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.

No intervention done

Intervention Type: OTHER

Not applicable because no intervention was done.

Interventions

No intervention done

Not applicable because no intervention was done.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National en Santé Publique du Québec

OTHER

Sponsor Role: collaborator

Ministere de la Sante et des Services Sociaux

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Caroline Quach-Thanh

MD, MSc, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Quach-Thanh, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Caroline Quach-Thanh, MD, MSc

Role: STUDY_DIRECTOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

The Montreal Children's Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 26546262 (View on PubMed)

Other Identifiers

MCH-ID-11-01

Identifier Type: -

Identifier Source: org_study_id