Rotavirus GastroenteritisNCT06882070
ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
An observational study of Rotavirus Gastroenteritis and Rotavirus Vaccines, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
Trial summary
Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis, Rotavirus Vaccines, Antimicrobial Resistance (AMR)
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 1,600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 May 2021to 4 Jun 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: The infants were from communities that are typical peri-urban settlements in Zambia and Ghana with informal housing, poor sanitation and mostly shared water supply from communal boreholes. These were high density communities with high unemployment rates and generally high incidence of infectious diseases.
Who may be able to join
- Healthy infants as established by medical history and clinical examination before randomisation into the study Age: ≥6 and <8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old) Parental ability and willingness to provide written informed consent. Intention of the participants' parents to remain in the area with the child during the study period
Who cannot join
- Acute disease at the time of enrollment/first study vaccination - temporary exclusion Presence of fever on the day of enrollment/first study vaccination (axillary temperature >37.6oC) Concurrent participation in another clinical trial (other than the parent study) throughout the entire timeframe for this study.
- Presence of severe malnutrition (weight-for-height z-score ≤-3SD median (per WHO published child growth standards) History of premature birth (<37 weeks gestation) and/or birth weight of <2.5 kg History of congenital abdominal disorders, intussusception, or abdominal surgery Prior receipt of rotavirus vaccine
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Ghana1 site
Noguchi Memorial Institute of Medical Research-University of Ghana
Accra
Zambia1 site
Center for Infectious Disease Research in Zambia
Lusaka, Lusaka Province, 10101
About this study
Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings. We hypothesized that effective rotavirus vaccination could reduce diarrhoeal episodes and thereby unnecessary antibiotic usage in young children in low-income settings.
The study aimed to evaluate the impact of rotavirus vaccination on antibiotic usage. Specifically, the study quantified how differences in rotavirus vaccine efficacy would impact days of prescription and nonprescription antibiotic usage in the first 2 years of life among two large cohorts of children in Zambia and Ghana.
Read more
The key goal was to understand the effect of rotavirus vaccine efficacy on antibiotic usage and household antibiotic costs. The goal was to generate evidence needed to inform policymakers seeking to introduce new rotavirus vaccines into national vaccination programs, of potential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage.
The study was conducted within a Phase III randomised controlled trial comparing the efficacy of a new parenteral trivalent P2-VP8 subunit rotavirus vaccine to the oral live attenuated vaccine, Rotarix®, against severe rotavirus gastroenteritis in the first 2 years of life in Zambia and Ghana.
- Conditions
- Rotavirus Gastroenteritis, Rotavirus Vaccines, Antimicrobial Resistance (AMR), Antibiotic, Microbiome, Infant Diarrhea
- Being tested
- Vaccine
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineOther
Also called trivalent P2-VP8 subunit rotavirus vaccine, oral live attenuated vaccine, Rotarix®
Trivalent P2-VP8 subunit rotavirus vaccine
| Study group | Role | What they receive |
|---|---|---|
| Trial cohort | This group received either the trivalent P2-VP8 subunit rotavirus vaccine or oral live attenuated vaccine, Rotarix®, Receives: Other: Vaccine | |
| Community cohort | This acted as control group, away from the vaccine trial groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing prescription and non-prescription antibiotic consumption in the first two years of life.
Measured: 2 years
Secondary outcomes (6)
• To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing recurrent antibiotic consumption in the first two years of life.
Measured: 2 years
• To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing household prescription and non-prescription antibiotic costs in the first two years of life.
Measured: 2 years
• To assess the background incidence of antibiotic usage in the community in the first two years of life.
Measured: 2 years
• To assess the relationship between frequency of antibiotic use and faecal bacterial microbiome composition, ARG abundance and bacterial metabolites in the urine over the first two years of life.
Measured: 2 years
• To assess the relationship between RVV efficacy (TV P2-VP8 and Rotarix) and faecal bacterial microbiome composition over the first two years of life.
Measured: 2 years
• Verification of weekly recall and medicine cabinet review of antibiotic use through assessment of antibiotic metabolites in the urine.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start4 May 2021
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus GastroenteritisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Centre for Infectious Disease Research in Zambia, Noguchi Memorial Institute for Medical Research, Amsterdam Institute for Global Health and Development
- Responsible party
- Principal investigator, Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882070
- Sponsor's protocol ID
- 219775/Z/19/Z
- Status last verified
- Dec 2024
- First submitted
- 12 Mar 2025
- Last updated
- 18 Mar 2025
- 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
- ClinicalTrials.gov ID
- NCT06882070
- Acronym / sponsor ID
- 219775/Z/19/Z
- Conditions
- Rotavirus Gastroenteritis, Rotavirus Vaccines, Antimicrobial Resistance (AMR), Antibiotic, Microbiome, Infant Diarrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Wellcome Trust, Centre for Infectious Disease Research in Zambia, Noguchi Memorial Institute for Medical Research, Amsterdam Institute for Global Health and Development
- Study start
- 4 May 2021 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 18 Mar 2025 (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.
Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings. We hypothesized that effective rotavirus vaccination could reduce diarrhoeal episodes and thereby unnecessary antibiotic usage in young children in low-income settings.
The study aimed to evaluate the impact of rotavirus vaccination on antibiotic usage. Specifically, the study quantified how differences in rotavirus vaccine efficacy would impact days of prescription and nonprescription antibiotic usage in the first 2 years of life among two large cohorts of children in Zambia and Ghana.
The key goal was to understand the effect of rotavirus vaccine efficacy on antibiotic usage and household antibiotic costs. The goal was to generate evidence needed to inform policymakers seeking to introduce new rotavirus vaccines into national vaccination programs, of potential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage.
The study was conducted within a Phase III randomised controlled trial comparing the efficacy of a new parenteral trivalent P2-VP8 subunit rotavirus vaccine to the oral live attenuated vaccine, Rotarix®, against severe rotavirus gastroenteritis in the first 2 years of life in Zambia and Ghana.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial cohort | – | Other: VaccineThis group received either the trivalent P2-VP8 subunit rotavirus vaccine or oral live attenuated vaccine, Rotarix®, |
| Community cohort | – | –This acted as control group, away from the vaccine trial groups |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The infants were from communities that are typical peri-urban settlements in Zambia and Ghana with informal housing, poor sanitation and mostly shared water supply from communal boreholes. These were high density communities with high unemployment rates and generally high incidence of infectious diseases.
Key inclusion criteria (1 listed)
- Healthy infants as established by medical history and clinical examination before randomisation into the study Age: ≥6 and <8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old) Parental ability and willingness to provide written informed consent. Intention of the participants' parents to remain in the area with the child during the study period
Key exclusion criteria (2 listed)
- Acute disease at the time of enrollment/first study vaccination - temporary exclusion Presence of fever on the day of enrollment/first study vaccination (axillary temperature >37.6oC) Concurrent participation in another clinical trial (other than the parent study) throughout the entire timeframe for this study.
- Presence of severe malnutrition (weight-for-height z-score ≤-3SD median (per WHO published child growth standards) History of premature birth (<37 weeks gestation) and/or birth weight of <2.5 kg History of congenital abdominal disorders, intussusception, or abdominal surgery Prior receipt of rotavirus vaccine
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 |
|---|---|---|
| VaccineAlso: trivalent P2-VP8 subunit rotavirus vaccine, oral live attenuated vaccine, Rotarix®Trivalent P2-VP8 subunit rotavirus vaccine | Other | Trial cohort |
Primary outcome
To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing prescription and non-prescription antibiotic consumption in the first two years of life.
Time frame: 2 years
6 secondary outcomes
• To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing recurrent antibiotic consumption in the first two years of life.
Time frame: 2 years
• To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing household prescription and non-prescription antibiotic costs in the first two years of life.
Time frame: 2 years
• To assess the background incidence of antibiotic usage in the community in the first two years of life.
Time frame: 2 years
• To assess the relationship between frequency of antibiotic use and faecal bacterial microbiome composition, ARG abundance and bacterial metabolites in the urine over the first two years of life.
Time frame: 2 years
• To assess the relationship between RVV efficacy (TV P2-VP8 and Rotarix) and faecal bacterial microbiome composition over the first two years of life.
Time frame: 2 years
• Verification of weekly recall and medicine cabinet review of antibiotic use through assessment of antibiotic metabolites in the urine.
Time frame: 2 years
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 18 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Gastroenteritis and Rotavirus Vaccines, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
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 1 inclusion and 2 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana, Zambia. 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.
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?
To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing prescription and non-prescription antibiotic consumption in the first two years of life. (time frame: 2 years). 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 18 Mar 2025.