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NCT Number: NCT01467037

Vaccine Effectiveness of RV1 in a Naïve Population

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.

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Key information

Conditions

Rotavirus Infections Diarrhea Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Reoviridae Infections Signs and Symptoms Signs and Symptoms, Digestive Virus Diseases

Age range

8 week–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention done

Other

Not applicable because no intervention was done.

Primary outcomes

  1. Matched VE Participants

    Time frame: From February 1, 2012 to May 31, 2014

    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 outcomes

  1. Vaccine Effectiveness of RV1

    Time frame: From February 1, 2012 to May 31, 2014

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • GlaxoSmithKline
  • Institut National en Santé Publique du Québec
  • Ministere de la Sante et des Services Sociaux

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2011
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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