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ACTIVE NOT RECRUITING

NCT02941107

PHASE4

Optimising Rotavirus Vaccine in Aboriginal Children

Sponsor: Telethon Kids Institute

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

6 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2018-03-27

Completion Date

2026-12

Last Updated

2024-03-06

Healthy Volunteers

Yes

Conditions

Viral Gastroenteritis Due to Rotavirus

Interventions

DRUG

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.

DRUG

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.

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 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

Locations (1)

Menzies School of Health Research

Darwin, Northern Territory, Australia