Safety of a heat-stable rotavirus vaccine among children in Niger: Data from a phase 3, randomized, double-blind, placebo-controlled trial

Vaccine
Matthew E ColdironRebecca F Grais

Abstract

Rotavirus remains a major cause of diarrhea among children under 5 years of age. The efficacy of RotaSIIL, a pentavalent rotavirus vaccine, was shown in an event-driven trial in Niger. We describe the two-year safety follow-up of this trial. Follow-up of safety outcomes began upon administration of the first dose of RotaSIIL or placebo. Adverse events were followed until 28 days after the third dose, and serious adverse events were followed until 2 years of age. Suspected cases of intussusception were evaluated at first point of contact and then referred to hospital for surgical evaluation. Causes of death were obtained by chart review and verbal autopsy. Passive surveillance was carried out in health centers. Community health workers carried out active surveillance in villages. Between-group differences were evaluated using the chi-squared test and Fisher's exact test. A total of 4092 children were randomized, and 4086 received at least one dose of RotaSIIL or placebo, constituting the intention-to-treat population, who accrued a total of 7385 child-years of follow-up time. At two years of follow-up, 58 (2.8%) participants who received RotaSIIL and 49 (2.4%) participants who received placebo had died (p = 0.38). Most deaths we...Continue Reading

Citations

Jul 16, 2019·Current Opinion in Infectious Diseases·Rachel M BurkeUmesh D Parashar
Oct 31, 2020·Human Vaccines & Immunotherapeutics·Annika SkansbergMary Carol Jennings
Nov 18, 2021·The Cochrane Database of Systematic Reviews·Hanna BergmanKarla Soares-Weiser
Aug 11, 2021·The Journal of Infectious Diseases·Rachel M BurkeUmesh D Parashar
Jan 9, 2022·Reviews in Medical Virology·Asma SadiqAamir Aziz

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