An observational study in Rotavirus Gastroenteritis, Rotavirus Vaccines and Antimicrobial Resistance (AMR), sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 2 sites in 2 countries. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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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.
26 studies on the registry are indexed under Diarrhea, Infantile; 5 are open to participants now.
Browse Diarrhea, Infantile studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 181 are open to participants now.
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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.
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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 . 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group received either the trivalent P2-VP8 subunit rotavirus vaccine or oral live attenuated vaccine, Rotarix®,
Other: Vaccine
This acted as control group, away from the vaccine trial groups
Trivalent P2-VP8 subunit rotavirus vaccine
Also known as: trivalent P2-VP8 subunit rotavirus vaccine, oral live attenuated vaccine, Rotarix®
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
• 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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2021 to primary completion in Jun 2024, 37 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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