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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02941107
Registration number
NCT02941107
Ethics application status
Date submitted
19/10/2016
Date registered
21/10/2016
Titles & IDs
Public title
Optimising Rotavirus Vaccine in Aboriginal Children
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Scientific title
The ORVAC Trial: A Phase IV, Double-blind, Randomised, Placebo-controlled Clinical Trial of a Third Scheduled Dose of RV1 Rotavirus Vaccine in Australian Indigenous Infants to Improve Protection Against Gastroenteritis
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Secondary ID [1]
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CVID/2015-03
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Universal Trial Number (UTN)
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Trial acronym
ORVAC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Viral Gastroenteritis Due to Rotavirus
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rotarix (RV1)
Treatment: Drugs - Placebo
Experimental: Rotarix - Rotarix (RV1) vaccine, 1mL liquid suspension administered orally.
Placebo comparator: Placebo - Placebo liquid suspension manufactured to mimic Rotarix (RV1) vaccine, 1ml administered orally
Treatment: Drugs: Rotarix (RV1)
ROTARIX™ (RV1) is a live-attenuated human monovalent oral vaccine containing attenuated G1P\[8\] human rotavirus strain sponsored and distributed in Australia by GlaxoSmithKline Biologicals where it is licensed for the prevention of rotavirus gastroenteritis.
Treatment: Drugs: Placebo
The placebo for this trial will be Viscosweet, a clear and flavoured solution used as a pharmaceutical excipient repackaged into a labelled syringe identical to the active and firmly sealed with an end cap.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time from randomisation to medical attendance for acute gastroenteritis or acute diarrhoea illness
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Assessment method [1]
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Time from randomisation to medical attendance (hospitalisation, emergency department presentation, medical clinic presentation) for which the primary reason for presentation is presumed or confirmed acute gastroenteritis or acute diarrhoea illness between randomisation and age 36 months.
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Timepoint [1]
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Randomisation to 36 months
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Primary outcome [2]
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Occurrence of anti-rotavirus IgA seroconversion
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Assessment method [2]
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Anti-rotavirus IgA seroconversion, defined as serum anti-rotavirus IgA \> 20U/ ml 28 to 55 days post RV1/placebo among infants with anti-rotavirus serum IgA \< 20U/ ml before RV1/placebo, to be summarised as the proportion of all children per group.
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Timepoint [2]
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28-55 Days post RV1/placebo administration
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Secondary outcome [1]
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Time from randomisation to hospitalisation for acute gastroenteritis or acute diarrhoea illness
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Assessment method [1]
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Time from randomisation to hospitalisation for which the primary coded reason for admission is presumed or confirmed acute gastroenteritis or acute diarrhoea illness between randomisation and age 36 months.
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Timepoint [1]
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Randomisation to 36 months
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Secondary outcome [2]
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Time from randomisation to hospitalisation for rotavirus confirmed diarrhoea illness
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Assessment method [2]
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Time from randomisation to hospitalisation for which rotavirus confirmed diarrhoea illness occurs between randomisation and age 36 months.
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Timepoint [2]
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Randomisation to 36 months
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Secondary outcome [3]
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Time from randomisation to Rotavirus infection
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Assessment method [3]
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Time from randomisation to rotavirus infection meeting the jurisdictional case definition between randomisation and age 36 months.
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Timepoint [3]
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Randomisation to 36 months
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Secondary outcome [4]
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Change in anti-rotavirus IgA log titre between administration of intervention (RV1/placebo) and 28 to 55 days post dose
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Assessment method [4]
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Change in anti-rotavirus IgA log titre between administration of intervention (RV1/placebo) and 28 to 55 days post dose, to be summarised as the proportion of all children per group.
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Timepoint [4]
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Randomisation and 28-55 days post RV1/placebo administration
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Secondary outcome [5]
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Occurrence of intussusception fulfilling Brighton criteria (see Appendix A)
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Assessment method [5]
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The occurrence of intussusception fulfilling Brighton criteria (see Appendix A) within the first 28 days after RV1/placebo administration, to be summarised as the proportion of all children per group.
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Timepoint [5]
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Within the first 28 days of RV1/placebo administration
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Secondary outcome [6]
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Occurrence of a serious adverse event
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Assessment method [6]
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Serious adverse events between randomisation and age 36 months, to be summarised as the proportion of all children per group.
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Timepoint [6]
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Randomisation to 36 months
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Secondary outcome [7]
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Medical attendance for confirmed acute gastroenteritis or acute diarrhoea illness between randomisation and 36 months gastroenteritis or acute diarrhoea illness.
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Assessment method [7]
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Medical attendance (hospitalisation, emergency department presentations, medical clinic presentations) from the time of randomisation to age 36 months, for which the primary reason for presentation is presumed or confirmed acute gastroenteritis or acute diarrhoea illness, to be summarised as the proportion of all children per group.
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Timepoint [7]
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Randomisation to 36 months
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Eligibility
Key inclusion criteria
* Aged = 6 months and < 12 months
* Identified as Aboriginal and/or Torres Strait Islander and/or South Sea Islander per attending legally responsible care-giver/parent.
* Have received either one or two prior doses of RV1 vaccination as confirmed by checking the immunisation register.
* Legally responsible care-giver/parent is willing for their infant to participate in the study and is aware of the requirements of the protocol.
* Legally responsible care-giver/parent is willing to allow other parties involved in the treatment of their child (including general practitioner, medical centre staff and any other medical professionals the child may be a patient of for the duration of the trial) to be notified of their participation in the trial and for participation in the trial to be recorded within the Northern Territory Immunisation Register.
* The legally responsible care-giver/parent is willing to allow the study team to obtain a vaccination history from Northern Territory Immunisation Register and/or the Australian Childhood Immunisation Register (ACIR) and/or local provider.
* The legally responsible care-giver/parent is willing to allow the study team to obtain a medical history from hospitalisation and laboratory databases, the disease notification register, the participant's electronic medical records and/or from the participant's primary care provider for the period from enrolment to age 36 months
* Informed consent for the infant's/child's participation in the study has been given by the legally responsible care-giver/parent
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Minimum age
6
Months
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Maximum age
12
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Has any contraindication for RV1 vaccination including:
* Severe combined immunodeficiency, any history of intussusception, any history of hypersensitivity to any vaccine component, or an uncorrected gastrointestinal tract malformation, receipt of more than two weeks of immunosuppressant or immune modifying drugs, (e.g. prednisolone > 0.5mg/kg/day) within 28 days of enrolment, confirmed or suspected severe immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection
* Receipt of any rotavirus vaccination other than RV1
* Receipt in the previous 3 months of any blood products including immunoglobulin
* Has received no prior doses or > two prior doses of RV1 vaccination
* Medical condition or treatment with medication which in the opinion of the clinic staff would make the child unsuitable for the trial
* Previously enrolled in the trial
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NT
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Recruitment hospital [1]
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Menzies School of Health Research - Darwin
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Recruitment postcode(s) [1]
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0810 - Darwin
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Funding & Sponsors
Primary sponsor type
Other
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Name
Telethon Kids Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Menzies School of Health Research
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02941107
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Trial related presentations / publications
Middleton BF, Danchin M, Jones MA, Leach AJ, Cunliffe N, Kirkwood CD, Carapetis J, Gallagher S, Kirkham LA, Granland C, McNeal M, Marsh JA, Waddington CS, Snelling TL. Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial. J Infect Dis. 2022 Nov 1;226(9):1537-1544. doi: 10.1093/infdis/jiac038. Jones MA, Graves T, Middleton B, Totterdell J, Snelling TL, Marsh JA. The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan. Trials. 2020 Aug 26;21(1):741. doi: 10.1186/s13063-020-04602-w. Middleton BF, Jones MA, Waddington CS, Danchin M, McCallum C, Gallagher S, Leach AJ, Andrews R, Kirkwood C, Cunliffe N, Carapetis J, Marsh JA, Snelling T. The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis. BMJ Open. 2019 Nov 14;9(11):e032549. doi: 10.1136/bmjopen-2019-032549.
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Public notes
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Contacts
Principal investigator
Name
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Tom Snelling
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Address
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Telethon Kids Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD (de-identified) may be shared with other research teams subject to approval of the statistical analysis plan, data transfer agreement and appropriate ethics. However, prior approvals may be required from lead ethics
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
post publication of study results
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Available to whom?
Researchers need to supply a statistical analysis plan and appropriate Ethics approvals
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02941107