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Optimising Rotavirus Vaccine in Aboriginal Children

Study acronym: ORVAC
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 6, 2024 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2020 to Jul 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2020 to Dec 2026
    • Site details revised
    v9
  2. Primary endpoints revised (2)
    • Secondary endpoints revised (7)
    v8
  3. Secondary endpoints: 6 to 7
    • Study description expanded, about 271 words
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Start date changed from estimate of Mar 2018 to Mar 27, 2018
    • Eligibility criteria shortened, about 40 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2017 to Mar 2018
    • Study sites: 0 to 1
    v4
  2. Start date: Dec 2016 to Oct 2017
    • Secondary endpoints: 8 to 6
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Australian Indigenous children, particularly those living in remote communities, suffer a disproportionately high burden of rotavirus gastroenteritis disease. Despite the introduction of rotavirus vaccine into the Northern Territory (NT) Immunisation Schedule in 2006, the rate of hospitalization for rotavirus in NT Aboriginal children \< 5 years continues to be high, and the rate ratio of rotavirus hospitalisations for Indigenous versus non-Indigenous children has actually increased. The reasons for sub-optimal vaccine response are not completely understood, but both reduced vaccine immune responses and low vaccine coverage are likely to be important factors. The purpose of this study is to determine if Aboriginal children who receive an additional dose of RV1 between the ages of 6 and 12 months, will have an increase anti-rotavirus serum IgA seroconversion and decreased medical presentations with gastroenteritis in the first three years of life, compared to those who receive placebo.
Trial Details
NCT Number NCT02941107
Lead Sponsor Telethon Kids Institute
Collaborators: Menzies School of Health Research
Conditions
(from sponsor)		 Viral Gastroenteritis Due to Rotavirus
Related terms Diarrhea
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov