Vaccine Effectiveness of RV1 in a Naïve Population

This study has been completed.
Sponsor:
Collaborators:
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
GlaxoSmithKline
Information provided by (Responsible Party):
Caroline Quach-Thanh, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01467037
First received: November 4, 2011
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Rotavirus Infections
Gastroenteritis
Diarrhea
Other: No intervention done

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vaccine Effectiveness of RV1 in a Naïve Population

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Matched VE Participants [ Time Frame: From February 1, 2012 to May 31, 2014 ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Vaccine Effectiveness of RV1 [ Time Frame: From February 1, 2012 to May 31, 2014 ] [ Designated as safety issue: No ]

    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.

    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 our analyses approximates the rate ratio.



Biospecimen Retention:   Samples Without DNA
stool sample

Enrollment: 374
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rotavirus-negative
Patients with a negative result for rotavirus via enzyme immunoassay (EIA). No intervention done.
Other: No intervention done
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.
Other: No intervention done
Not applicable because no intervention was done.

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

Ages Eligible for Study:   8 Weeks to 3 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01467037

Locations
Canada, Quebec
The Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine
Montréal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
McGill University Health Center
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
GlaxoSmithKline
Investigators
Principal Investigator: Caroline Quach-Thanh, MD, MSc McGill University Health Center
Study Director: Caroline Quach-Thanh, MD, MSc McGill University Health Center
  More Information

Publications:
Responsible Party: Caroline Quach-Thanh, MD, MSc, FRCPC, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01467037     History of Changes
Other Study ID Numbers: MCH-ID-11-01 
Study First Received: November 4, 2011
Results First Received: November 16, 2015
Last Updated: March 17, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Rotavirus
Gastroenteritis
Vaccination
Pediatrics

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Rotavirus Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 24, 2016