A Phase 4 interventional study of Rotarix (RV1) and Placebo in Viral Gastroenteritis Due to Rotavirus, sponsored by Telethon Kids Institute. Active, not recruiting at 1 site in Australia. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Telethon Kids Institute · Phase 4, Interventional, and Prevention
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.
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.
This study will enrol Aboriginal infants aged 6 months to \< 12 months old who have received one or two prior doses of RV1. The coprimary aim is to determine whether an oral dose of RV1 vaccine at age 6 months to less than 12 months, compared to placebo, results in an increase in the average time to medical attendance for gastroenteritis before age 36 months (co-primary endpoint 1), and/ or superior immune protection against rotavirus gastroenteritis assessed approximately 1 to 2 months after vaccination (co-primary endpoint 2), in Australian Indigenous children.
This is a phase IV, randomised, placebo-controlled Bayesian trial with two strata representing residency based on a standard geographical classification of remoteness. It has the following key features:
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Telethon Kids Institute is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Has any for RV1 vaccination including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rotarix (RV1) vaccine, 1mL liquid suspension administered orally.
Drug: Rotarix (RV1)
Placebo liquid suspension manufactured to mimic Rotarix (RV1) vaccine, 1ml administered orally
Drug: Placebo
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.
Also known as: ROTARIX™
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.
Also known as: Viscosweet
Time from randomisation to medical attendance for acute gastroenteritis or acute diarrhoea illness
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.
Time frame: Randomisation to 36 months
Occurrence of anti-rotavirus IgA seroconversion
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.
Time frame: 28-55 Days post RV1/placebo administration
Time from randomisation to hospitalisation for acute gastroenteritis or acute diarrhoea illness
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.
Time frame: Randomisation to 36 months
Time from randomisation to hospitalisation for rotavirus confirmed diarrhoea illness
Time from randomisation to hospitalisation for which rotavirus confirmed diarrhoea illness occurs between randomisation and age 36 months.
Time frame: Randomisation to 36 months
Time from randomisation to Rotavirus infection
Time from randomisation to rotavirus infection meeting the jurisdictional case definition between randomisation and age 36 months.
Time frame: Randomisation to 36 months
Change in anti-rotavirus IgA log titre between administration of intervention (RV1/placebo) and 28 to 55 days post dose
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.
Time frame: Randomisation and 28-55 days post RV1/placebo administration
Occurrence of intussusception fulfilling Brighton criteria (see Appendix A)
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.
Time frame: Within the first 28 days of RV1/placebo administration
Occurrence of a serious adverse event
Serious adverse events between randomisation and age 36 months, to be summarised as the proportion of all children per group.
Time frame: Randomisation to 36 months
Medical attendance for confirmed acute gastroenteritis or acute diarrhoea illness between randomisation and 36 months gastroenteritis or acute diarrhoea illness.
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.
Time frame: Randomisation to 36 months
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: post publication of study results
Access criteria: Researchers need to supply a statistical analysis plan and appropriate Ethics approvals
Started Mar 2018 (actual). Primary completion is estimated for Jul 2026, 100 months after the start.
Of 32 non-industry phase 4 interventional studies under Diarrhea, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 100 months is above that.
Counting every sponsor, half of 37 studies reached it within 32 months; a quarter within 14 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: RIX4414 vaccine
Telethon Kids Institute