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dc.creatorStevanović, Goran
dc.creatorObradović, Aleksandar
dc.creatorRistić, Snezana
dc.creatorPetrović, Dragan
dc.creatorMilenković, Branislava
dc.creatorMitrović, Danilo
dc.creatorVignjević Filipović, Svetlana
dc.creatorIlić, Katarina
dc.creatorStoiljković, Vera
dc.creatorLavadinović, Lidija
dc.creatorPelemis, Mijomir
dc.creatorPetrović, Svetlana
dc.creatorVidmanić, Ana
dc.creatorPopović, Olga
dc.creatorEremić, Natasa
dc.creatorSparrow, Erin
dc.creatorTorelli, Guido
dc.creatorSocquet, Muriel
dc.creatorHolt, Renée
dc.creatorIlieva-Borisova, Yordanka
dc.creatorTang, Yuxiao
dc.creatorScorza, Francesco Berlanda
dc.creatorFlores, Jorge
dc.creatorRathi, Niraj
dc.date.accessioned2022-02-22T08:48:50Z
dc.date.available2022-02-22T08:48:50Z
dc.date.issued2020
dc.identifier.issn2515-1355
dc.identifier.urihttp://intor.torlakinstitut.com/handle/123456789/616
dc.description.abstractThis study was a phase III, multicenter, double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a seasonal trivalent split, inactivated influenza vaccine (TIV) in healthy Serbian adults between the ages of 18 and 65 years. This egg-based vaccine was manufactured by the Institute of Virology, Vaccines and Sera, Torlak, Belgrade, Serbia. A total of 480 participants were assigned randomly in a ratio of 2:1 to receive a single intramuscular dose (0.5 ml) of the vaccine (15 µg of hemagglutinin per strain) or placebo (phosphate-buffered saline). Participants were monitored for safety, including solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs). No SAEs related to vaccination were reported. Injection site pain (51.3%), injection site tenderness (40.4%), tiredness (17.0%), and headache (15.1%) were the most commonly reported solicited events in the vaccine group. Incidence of related unsolicited AEs was low (1.3%) among vaccinees. Hemagglutinin inhibition (HAI) titers were measured before and 21 days after vaccination in 151 participants. Overall, HAI seroconversion rates to H1 and H3 were observed in 90.1% and 76.2% of vaccinees, respectively. For B antigen, it was 51.5%, likely due to high pre-vaccination titers. Post-vaccination seroprotection rates were in the range of 78.2–95.0% for the three antigens. Post-vaccination geometric mean titers (GMT) were at least 3.8 times higher than baseline levels for all the three strains among vaccinees. Overall, the study showed that the vaccine was safe and well tolerated, and induced a robust immune response against all three vaccine strains., ClinicalTrials.gov identifier: NCT02935192, October 17, 2016
dc.languageen
dc.publisherSAGE Publications
dc.relationUS Department of Health and Human Services/BARDA grant Number IDSEP130015-01
dc.relationUS Department of Health and Human Services/BARDA grant Number IDSEP130018-01-06
dc.rightsopenAccess
dc.sourceTherapeutic Advances in Vaccines and Immunotherapy
dc.subjectclinical trial
dc.subjectseasonal influenza vaccine
dc.subjectSerbia
dc.subjectTorlak
dc.subjecttrivalent inactivated split
dc.titleSafety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults
dc.typearticleen
dc.rights.licenseBY-NC
dc.citation.volume8
dc.identifier.doi10.1177/2515135520925336
dc.identifier.scopus2-s2.0-85118420286
dc.type.versionpublishedVersion


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