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NCT Number: NCT06882070

ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage

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.

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Key information

Conditions

Rotavirus Gastroenteritis Antibiotic Antimicrobial Resistance (AMR) Diarrhea Diarrhea, Infantile Infant Diarrhea Microbiome Pathological Conditions, Signs and Symptoms Rotavirus Vaccines Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Noguchi Memorial Institute of Medical Research-University of Ghana, Accra, Ghana

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Vaccine

Other

Trivalent P2-VP8 subunit rotavirus vaccine

Other names: trivalent P2-VP8 subunit rotavirus vaccine, oral live attenuated vaccine, Rotarix®

Primary outcomes

  1. 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

Secondary outcomes

  1. • 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

  2. • 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

  3. • To assess the background incidence of antibiotic usage in the community in the first two years of life.

    Time frame: 2 years

  4. • 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

  5. • 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

  6. • Verification of weekly recall and medicine cabinet review of antibiotic use through assessment of antibiotic metabolites in the urine.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Amsterdam Institute for Global Health and Development
  • Centre for Infectious Disease Research in Zambia
  • Noguchi Memorial Institute for Medical Research
  • Wellcome Trust

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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