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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

November 4, 2011
March 17, 2016
February 2012
December 2014   (final data collection date for primary outcome measure)
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.

ED visit or admission for RV+ sample [ Time Frame: Within 7 days of symptoms ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01467037 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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.

Not Provided
 
Vaccine Effectiveness of RV1 in a Naïve Population
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
stool sample
Non-Probability Sample
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.
  • Rotavirus Infections
  • Gastroenteritis
  • Diarrhea
Other: No intervention done
Not applicable because no intervention was done.
  • Rotavirus-negative
    Patients with a negative result for rotavirus via enzyme immunoassay (EIA). No intervention done.
    Intervention: 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.
    Intervention: Other: No intervention done
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):7307-14. doi: 10.1016/j.vaccine.2015.10.118. Epub 2015 Nov 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
8 Weeks to 3 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01467037
MCH-ID-11-01
No
Not Provided
Not Provided
Caroline Quach-Thanh, McGill University Health Center
McGill University Health Center
  • Institut National en Santé Publique du Québec
  • Ministere de la Sante et des Services Sociaux
  • GlaxoSmithKline
Principal Investigator: Caroline Quach-Thanh, MD, MSc McGill University Health Center
Study Director: Caroline Quach-Thanh, MD, MSc McGill University Health Center
McGill University Health Center
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP