Viral Gastroenteritis Due to RotavirusPhase 4ORVACNCT02941107
Optimising Rotavirus Vaccine in Aboriginal Children
A Phase 4 study testing Rotarix (RV1) in people with Viral Gastroenteritis Due to Rotavirus, run by Telethon Kids Institute at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Viral Gastroenteritis Due to Rotavirus
- What is being tested?
- Rotarix (RV1)
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Mar 2018to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Menzies School of Health Research
Darwin, Northern Territory, 0810
About this study
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
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.
Read the detailed description
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:
- Double-blind, randomised, placebo-controlled trial;
- The procedures for enrolment, intervention, end-point and analysis are based on the principles of pragmatic trial design;
- Non-fixed sample size up to 1,000 participants based on Bayesian stopping rules;
- Fixed 1:1 enrolment into the active and control arm throughout the trial;
- Frequent interim analyses can result in the trial stopping early for futility or expected success.
- Conditions
- Viral Gastroenteritis Due to Rotavirus
- Being tested
- Rotarix (RV1), Placebo
- Keywords
- Aboriginal, Rotavirus, Vaccine, Diarrhoea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarix (RV1)Drug
Also called ROTARIX™
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.
PlaceboDrug
Also called Viscosweet
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.
| Study group | Role | What they receive |
|---|---|---|
| Rotarix | Experimental | Rotarix (RV1) vaccine, 1mL liquid suspension administered orally. Receives: Drug: Rotarix (RV1) |
| Placebo | Placebo comparator | Placebo liquid suspension manufactured to mimic Rotarix (RV1) vaccine, 1ml administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28-55 Days post RV1/placebo administration
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Randomisation to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start27 Mar 2018
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Viral Gastroenteritis Due to RotavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Menzies School of Health Research
- Responsible party
- Sponsor
- Investigators
- Tom Snelling, Principal investigator, Telethon Kids Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941107
- Sponsor's protocol ID
- CVID/2015-03
- Acronym
- ORVAC
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2016
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
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.
PubMed 35134951Jones 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.
PubMed 32843086Middleton 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.
PubMed 31727664
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02941107
- Acronym / sponsor ID
- ORVAC / CVID/2015-03
- Conditions
- Viral Gastroenteritis Due to Rotavirus
- Keywords
- Aboriginal, Rotavirus, Vaccine, Diarrhoea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Collaborators
- Menzies School of Health Research
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Double-blind, randomised, placebo-controlled trial;
- The procedures for enrolment, intervention, end-point and analysis are based on the principles of pragmatic trial design;
- Non-fixed sample size up to 1,000 participants based on Bayesian stopping rules;
- Fixed 1:1 enrolment into the active and control arm throughout the trial;
- Frequent interim analyses can result in the trial stopping early for futility or expected success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotarix | Experimental | Drug: Rotarix (RV1)Rotarix (RV1) vaccine, 1mL liquid suspension administered orally. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo liquid suspension manufactured to mimic Rotarix (RV1) vaccine, 1ml administered orally |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotarix (RV1)Also: ROTARIX™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 | Rotarix |
| PlaceboAlso: ViscosweetThe 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. | Drug | Placebo |
Primary outcome
Time from randomisation to medical attendance for acute gastroenteritis or acute diarrhoea illness
Time frame: Randomisation to 36 months
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.
Occurrence of anti-rotavirus IgA seroconversion
Time frame: 28-55 Days post RV1/placebo administration
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.
7 secondary outcomes
Time from randomisation to hospitalisation for acute gastroenteritis or acute diarrhoea illness
Time frame: Randomisation to 36 months
Time from randomisation to hospitalisation for rotavirus confirmed diarrhoea illness
Time frame: Randomisation to 36 months
Time from randomisation to Rotavirus infection
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
Time frame: Randomisation and 28-55 days post RV1/placebo administration
Occurrence of intussusception fulfilling Brighton criteria (see Appendix A)
Time frame: Within the first 28 days of RV1/placebo administration
Occurrence of a serious adverse event
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.
Time frame: Randomisation to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 35134951Middleton 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.
- Derived from this study: PubMed 32843086Jones 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.
- Derived from this study: PubMed 31727664Middleton 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.
- Individual participant dataSharing planned: 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Snelling principal investigator
Telethon Kids Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotarix (RV1) in people with Viral Gastroenteritis Due to Rotavirus, run by Telethon Kids Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomisation to medical attendance for acute gastroenteritis or acute diarrhoea illness (time frame: Randomisation to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941107, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.