N/A
N=374
Vaccine Effectiveness of RV1 in a Naïve Population
Rotavirus Infections · Gastroenteritis · Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT01467037 ↗Enrolled (actual)
374
Serious AEs
—
Results posted
Jan 2016
Primary outcome: Primary: Matched VE Participants — 26; 22; 16; 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention done (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Matched VE Participants |
26; 22; 16; 1; 114; 7 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01467037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.