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

NCT ID: NCT06882070

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2024-06-04

Brief 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. 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.

Conditions

Rotavirus Gastroenteritis; Rotavirus Vaccines; Antimicrobial Resistance (AMR); Antibiotic; Microbiome; Infant Diarrhea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Trial cohort

This group received either the trivalent P2-VP8 subunit rotavirus vaccine or oral live attenuated vaccine, Rotarix®,

Vaccine

Intervention Type: OTHER

Trivalent P2-VP8 subunit rotavirus vaccine

Community cohort

This acted as control group, away from the vaccine trial groups

No interventions assigned to this group

Interventions

Vaccine

Trivalent P2-VP8 subunit rotavirus vaccine

Intervention Type: OTHER

Other Intervention Names

trivalent P2-VP8 subunit rotavirus vaccine; oral live attenuated vaccine, Rotarix®

Eligibility Criteria

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wellcome Trust

OTHER

Sponsor Role: collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: collaborator

Noguchi Memorial Institute for Medical Research

OTHER

Sponsor Role: collaborator

Amsterdam Institute for Global Health and Development

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Harris

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Noguchi Memorial Institute of Medical Research-University of Ghana

Accra, , Ghana

Center for Infectious Disease Research in Zambia

Lusaka, Lusaka Province, Zambia

Countries

Ghana; Zambia

Other Identifiers

219775/Z/19/Z

Identifier Type: -

Identifier Source: org_study_id