Vaccine Effectiveness of RV1 in a Naïve Population

Diarrhea Clinical Trial

Official title:

Vaccine Effectiveness of RV1 in a Naïve Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467037
• Other study ID #: MCH-ID-11-01
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: December 18, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Weeks to 3 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diarrhea
• Gastroenteritis
• Rotavirus Infections

Intervention

Other:
• No intervention done
Not applicable because no intervention was done.

Locations

Country	Name	City	State
Canada	The Montreal Children's Hospital	Montreal	Quebec
Canada	Centre Hospitalier Universitaire Sainte-Justine	Montréal	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
McGill University Health Center	GlaxoSmithKline, Institut National en Santé Publique du Québec, Ministere de la Sante et des Services Sociaux

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine Effectiveness of RV1	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 [32], and the recommended age of second dose administration, respectively.; We estimated RV1 VE of 2- versus 0-doses and =1- versus 0-dose to prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered =14 days prior to symptom onset were considered. RV1 VE was estimated as (1 - exposure odds ratio) × 100. Based upon our sampling scheme, the exposure odds ratio from ouranalyses approximates the rate ratio	From February 1, 2012 to May 31, 2014	No