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Optimising Rotavirus Vaccine in Aboriginal Children (ORVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02941107
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : August 22, 2019
Menzies School of Health Research
Information provided by (Responsible Party):
Telethon Kids Institute

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.

Condition or disease Intervention/treatment Phase
Viral Gastroenteritis Due to Rotavirus Drug: Rotarix (RV1) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arm Intervention/treatment
Experimental: Rotarix
Rotarix (RV1) vaccine, 1mL liquid suspension administered orally.
Drug: Rotarix (RV1)

Placebo Comparator: Placebo
Placebo liquid suspension manufactured to mimic Rotarix (RV1) vaccine, 1ml administered orally
Drug: Placebo

Primary Outcome Measures :
  1. Time from randomisation to medical attendance (hospitalisation,emergency department or medical clinic presentation) for which primary reason for presentation is presumed or confirmed acute gastroenteritis or acute diarrhoea illness before age 36 months [ Time Frame: Enrolment to 36 months ]
  2. 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. [ Time Frame: 28-55 Days post RV1/placebo administration ]

Secondary Outcome Measures :
  1. Time from randomisation to hospitalisation for which the primary coded reason for admission is presumed or confirmed acute gastroenteritis or acute diarrhoea illness before age 36 months. [ Time Frame: Enrolment to 36 months ]
  2. Time from randomisation to hospitalisation for which rotavirus confirmed diarrhoea illness occurs before age 36 months. [ Time Frame: Enrolment to 36 months ]
  3. Rotavirus infection meeting the jurisdictional case definition [ Time Frame: Enrolment to 36 months ]
  4. Change in anti-rotavirus IgA log titre between administration of intervention (RV1/placebo) and 28 to 55 days post dose [ Time Frame: Enrolment and 28-55 days post RV1/placebo administration ]
  5. The occurrence of intussusception fulfilling Brighton criteria (see Appendix A) [ Time Frame: Within the first 28 days of RV1/placebo administration ]
  6. Serious adverse events [ Time Frame: Enrolment to 36 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02941107

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Contact: Tom Snelling 0401355389
Contact: Nelly Newall

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Australia, Northern Territory
Menzies School of Health Research Recruiting
Darwin, Northern Territory, Australia, 0810
Contact: Tom Snelling, Dr   
Principal Investigator: Dennis Bonney, Dr         
Sponsors and Collaborators
Telethon Kids Institute
Menzies School of Health Research
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Principal Investigator: Tom Snelling Telethon Kids Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Telethon Kids Institute Identifier: NCT02941107    
Other Study ID Numbers: CVID/2015-03
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Telethon Kids Institute:
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases