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dc.contributor.authorLau, Yu-Lung
dc.contributor.authorFan Leung, Ting
dc.contributor.authorSirvan Cetin, Benhur
dc.contributor.authorCagri Dinleyici, Ener
dc.contributor.authorHuang, Li-Min
dc.contributor.authorHalperin, Scott A
dc.contributor.authorHsiao, Chien-Chou
dc.contributor.authorTapiero, Bruce
dc.contributor.authorTipton, Mary
dc.contributor.authorCampbell, James D
dc.contributor.authorMoerman, Leentje
dc.contributor.authorPovey, Michael
dc.contributor.authorBi, Dan
dc.contributor.authorSingh, Tina
dc.date.accessioned2022-03-07T14:02:34Z
dc.date.available2022-03-07T14:02:34Z
dc.date.issued2022-02-26
dc.identifier.urihttp://hdl.handle.net/10713/18164
dc.description.abstractBackground: The introduction of rotavirus vaccines in national immunization programs has decreased mortality and hospitalizations due to diarrhea. GSK's live-attenuated, human rotavirus vaccine (HRV) is a 2-dose vaccine for oral administration. Following the detection of porcine circovirus type 1 (PCV-1) in HRV, a PCV-free (no detection of PCV-1 and PCV-2 according to the detection limits of tests used) HRV was developed. The immunogenicity, reactogenicity and safety of a liquid (liq) PCV-free HRV were assessed in two prior studies. The present study aimed to generate additional reactogenicity and safety data. Methods: This phase III, observer-blind, randomized, controlled multi-country study enrolled healthy 6–12-week-old infants. Infants were randomized to receive 2 doses of either the liq PCV-free HRV (N = 677) or the lyophilized (lyo) HRV (N = 674) 1–2 months apart. Solicited adverse events (AEs) were recorded for 8 days after each dose, unsolicited AEs for 31 days and serious AEs (SAEs) from dose 1 until the end of the 6-month safety follow-up. Results: The occurrence of solicited general AEs was comparable between the liq PCV-free HRV and the lyo HRV groups, with irritability/fussiness being the most frequently reported (74.9% [95% confidence interval: 71.4–78.1] and 72.1% [68.6–75.5]). Unsolicited AEs were reported for 29.7% (26.3–33.3) and 30.6% (27.1–34.2) of infants in the liq PCV-free HRV and the lyo HRV group. A total of 39 and 38 infants reported at least one SAE, respectively. The most common SAEs were upper respiratory tract (0.7% and 0.9%) and urinary tract infections (0.9% and 0.6%). One SAE (constipation) in the liq PCV-free HRV group was considered as potentially causally related to vaccination by the investigator. No deaths were reported. Conclusions: The study showed that the reactogenicity and safety profiles of the liq PCV-free HRV and the lyo HRV are similar. ClinicalTrials.gov identifier: NCT0395474.en_US
dc.description.urihttps://doi.org/10.1016/j.vaccine.2022.02.065en_US
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.ispartofVaccineen_US
dc.rightsCopyright © 2022. Published by Elsevier Ltd.en_US
dc.subjectHuman rotavirus vaccineen_US
dc.subjectInfanten_US
dc.subjectLiquiden_US
dc.subjectPorcine circovirus-freeen_US
dc.subjectReactogenicityen_US
dc.subjectSafetyen_US
dc.titleSafety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study.en_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.vaccine.2022.02.065
dc.identifier.pmid35232596
dc.source.journaltitleVaccine
dc.source.countryNetherlands


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