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    Safety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study.

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    Author
    Lau, Yu-Lung
    Fan Leung, Ting
    Sirvan Cetin, Benhur
    Cagri Dinleyici, Ener
    Huang, Li-Min
    Halperin, Scott A
    Hsiao, Chien-Chou
    Tapiero, Bruce
    Tipton, Mary
    Campbell, James D
    Moerman, Leentje
    Povey, Michael
    Bi, Dan
    Singh, Tina
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    Date
    2022-02-26
    Journal
    Vaccine
    Publisher
    Elsevier
    Type
    Article
    
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    https://doi.org/10.1016/j.vaccine.2022.02.065
    Abstract
    Background: 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.
    Rights/Terms
    Copyright © 2022. Published by Elsevier Ltd.
    Keyword
    Human rotavirus vaccine
    Infant
    Liquid
    Porcine circovirus-free
    Reactogenicity
    Safety
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/18164
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.vaccine.2022.02.065
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