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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Mar 12, 2025

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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