RotavirusPhase 4NCT03587389
Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam
A Phase 4 study testing Rotarix vaccine in people with Rotavirus and Diarrhea, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial summary
The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam. Read more about this study
- Who is it for?
- Ages 8 to 9 weeksHealthy volunteers can take part
- What is being tested?
- Rotarix vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 1 siteVietnam
- Study dates
- 19 Mar 2019to 8 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 8 to 9 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants (both males and females) between 8 and 9 weeks (i.e. approximately 2 months) of age who are attending Hung Vuong Hospital to receive their standard EPI vaccinations.
- Currently registered residents of Districts 5 (where Hung Vuong Hospital is located) or 1, 6, 8, 10, or 11 (districts that are neighbouring district 5) in Ho Chi Minh city, with no specific intention of relocating in the next 12 months.
- Informed consent to be enrolled in the study and comply with study procedures, including host genetic studies.
Who cannot join
- Refusal of consent.
- Parent/ guardian under the age of 18.
- Premature (i.e. gestation period <37 weeks).
- Infants who have already been immunized with either a rotavirus vaccine or the standard 2-month EPI vaccinations.
- History of hypersensitivity to any components of the vaccine or adverse vaccine event.
- History of intussusception or congenital malformation of the gastrointestinal tract in the child that is likely to predispose child to intussusception.
- History of severe combined immunodeficiency disease (SCID), acquired immune deficiency syndrome (AIDS) or Human immunodeficiency virus (HIV) positivity, or other known immunodeficiency syndromes that may place the child at risk during immunisation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Single-arm Interventional Study to Identify the Influence of Human Genetic Variation on Early Transcriptional Responses and Protective Immunity Following Immunization With Rotarix Rotavirus Vaccine in Infants in HCM City in Vietnam
The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam.
The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.
Read the detailed description
This study will be an open single arm, single centre, interventional study conducted in Ho Chi Minh City, Vietnam. A sample size of 1,000 infants will be recruited to the study between 8 to 9 weeks (which is around 2 months) of age. These infants will receive two doses of the rotavirus vaccine, Rotarix with an interval of 28-37 days (or 4-5 weeks). The parents will be requested to bring the infants 2-3 days following each Rotarix vaccination to receive the standard EPI vaccinations. The infants will then be under passive and active surveillance for rotavirus-associated diarrhoea until 18 months of age. Blood samplings during pre and post vaccination and at 6, 12 and 18 month old visits will be collected.
- Being tested
- Rotarix vaccine
- Keywords
- Rotavirus, Vaccine, Diarrhea, Host genetics
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarix vaccineBiological
In this study, the 1st dose of Rotarix vaccine will be administered when infants are at ages between weeks 8-9 and the 2nd dose is 28-37 days after the 1st dose, which means that there is an interval of 28-37 days or 4-5 weeks between doses. A reminding call will be set at about 4 weeks after the 1st dose to remind parents to bring their children back to Hung Vuong Hospital for the 2nd dose of Rotarix to ensure the completion of the 2nd dose of Rotarix vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Rotavirus vaccine | Experimental | The Rotarix vaccine package consist of 1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1.
The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. Rotarix is for oral use only and should under no circumstancies be injected.
All participating infants will receive two doses of Rotarix vaccine following the standard Rotarix immunization protocol. Receives: Biological: Rotarix vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.
The primary endpoint is to measure the proportion of rotavirus vaccine failure events during the time period from recruitment to 18 months of age after the first dose of vaccination.
Measured: from the recruitment to 18 months of age after the first dose of vaccination
Secondary outcomes (2)
Quantification of the antibody response following immunization
The temporal kinetics of rotavirus-specific antibody responses following immunization will be measured using virus-binding enzyme-linked immunosorbent assay (ELISA), which will be used to investigate the effect of host genetics, maternally transferred antibodies, and geospatial and epidemiological factors on the humoral response following vaccination.
Measured: data collected during 7 site visits (Visit 1: Rotarix Dose 1, Visit 2: 2-3 after Visit 1, Visit 3: 28-37 days after Visit 1, Visit 4: 2-3 days after Visit 3, Visit 5: 6 months old, Visit 6: 12 months old, Visit 7: 18 months old)
Assessment of infecting rotavirus genotypes in vaccine failure cases
The rotavirus genotypes in vaccine failure cases will be assessed to investigate whether vaccine failure cases are a result of varying rotavirus genotypes.
Measured: from the recruitment to 18 months of age after the first dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start19 Mar 2019
- Primary completion30 Jun 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hung Vuong Hospital, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Wellcome Sanger Institute
- Responsible party
- Sponsor
- Investigators
- Stephen Baker, Professor, Principal investigator, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587389
- Sponsor's protocol ID
- 21EN
- Status last verified
- Nov 2022
- First submitted
- 17 Apr 2018
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Single-arm Interventional Study to Identify the Influence of Human Genetic Variation on Early Transcriptional Responses and Protective Immunity Following Immunization With Rotarix Rotavirus Vaccine in Infants in HCM City in Vietnam
- ClinicalTrials.gov ID
- NCT03587389
- Acronym / sponsor ID
- 21EN
- Keywords
- Rotavirus, Vaccine, Diarrhea, Host genetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Hung Vuong Hospital, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Wellcome Sanger Institute
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 16 Jul 2018 (actual)
- 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.
The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam.
The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.
Detailed description
This study will be an open single arm, single centre, interventional study conducted in Ho Chi Minh City, Vietnam. A sample size of 1,000 infants will be recruited to the study between 8 to 9 weeks (which is around 2 months) of age. These infants will receive two doses of the rotavirus vaccine, Rotarix with an interval of 28-37 days (or 4-5 weeks). The parents will be requested to bring the infants 2-3 days following each Rotarix vaccination to receive the standard EPI vaccinations. The infants will then be under passive and active surveillance for rotavirus-associated diarrhoea until 18 months of age. Blood samplings during pre and post vaccination and at 6, 12 and 18 month old visits will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotavirus vaccine | Experimental | Biological: Rotarix vaccineThe Rotarix vaccine package consist of 1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1. The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. Rotarix is for oral use only and should under no circumstancies be injected. All participating infants will receive two doses of Rotarix vaccine following the standard Rotarix immunization protocol. |
Who may qualify
- Ages
- 8 to 9 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants (both males and females) between 8 and 9 weeks (i.e. approximately 2 months) of age who are attending Hung Vuong Hospital to receive their standard EPI vaccinations.
- Currently registered residents of Districts 5 (where Hung Vuong Hospital is located) or 1, 6, 8, 10, or 11 (districts that are neighbouring district 5) in Ho Chi Minh city, with no specific intention of relocating in the next 12 months.
- Informed consent to be enrolled in the study and comply with study procedures, including host genetic studies.
Key exclusion criteria (7 listed)
- Refusal of consent.
- Parent/ guardian under the age of 18.
- Premature (i.e. gestation period <37 weeks).
- Infants who have already been immunized with either a rotavirus vaccine or the standard 2-month EPI vaccinations.
- History of hypersensitivity to any components of the vaccine or adverse vaccine event.
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 vaccineIn this study, the 1st dose of Rotarix vaccine will be administered when infants are at ages between weeks 8-9 and the 2nd dose is 28-37 days after the 1st dose, which means that there is an interval of 28-37 days or 4-5 weeks between doses. A reminding call will be set at about 4 weeks after the 1st dose to remind parents to bring their children back to Hung Vuong Hospital for the 2nd dose of Rotarix to ensure the completion of the 2nd dose of Rotarix vaccine. | Biological | Rotavirus vaccine |
Primary outcome
The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.
Time frame: from the recruitment to 18 months of age after the first dose of vaccination
The primary endpoint is to measure the proportion of rotavirus vaccine failure events during the time period from recruitment to 18 months of age after the first dose of vaccination.
2 secondary outcomes
Quantification of the antibody response following immunization
Time frame: data collected during 7 site visits (Visit 1: Rotarix Dose 1, Visit 2: 2-3 after Visit 1, Visit 3: 28-37 days after Visit 1, Visit 4: 2-3 days after Visit 3, Visit 5: 6 months old, Visit 6: 12 months old, Visit 7: 18 months old)
Assessment of infecting rotavirus genotypes in vaccine failure cases
Time frame: from the recruitment to 18 months of age after the first dose of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Stephen Baker, Professor principal investigator
Oxford University Clinical Research Unit
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 vaccine in people with Rotavirus and Diarrhea, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
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 3 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: finished, as of the sponsor's last update on 14 Nov 2022. 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 Vietnam. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rotavirus vaccine failure events during the time period from recruitment to 18 months of age. (time frame: from the recruitment to 18 months of age after the first dose of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2022.