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
Trial Information
Current as of April 23, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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
About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)
The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Accra, , Ghana
Lusaka, , Zambia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported