ROTA-biotic: measuring the impact of rotavirus vaccines on pediatric antibiotic usage (360G-Wellcome-219775_Z_19_Z)

Rotavirus is the most common aetiology of serious gastroenteritis in young children. Despite antibiotics not being indicated in its treatment, gastroenteritis remains a very common cause for antibiotic prescribing in low-income settings. We hypothesize that effective rotavirus vaccination can reduce diarrheal episodes and thereby unnecessary antibiotic usage in young children in low-income settings. This study aims to evaluate the impact of rotavirus vaccination on antibiotic usage. Specifically, the study will quantify how differences in rotavirus vaccine efficacy impact days of prescription and non-prescription antibiotic usage in the first 2 years of life among two large cohorts of children in Zambia and Ghana. The key goal is to understand the effect of rotavirus vaccine efficacy on antibiotic usage and household antibiotic costs. This will generate evidence needed to inform policy-makers seeking to introduce new rotavirus vaccines into national vaccination programmes, ofpotential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage. This proposal will be conducted within a planned 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.