Vidmanić, Ana

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  • Vidmanić, Ana (1)
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Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults

Stevanović, Goran; Obradović, Aleksandar; Ristić, Snezana; Petrović, Dragan; Milenković, Branislava; Mitrović, Danilo; Vignjević Filipović, Svetlana; Ilić, Katarina; Stoiljković, Vera; Lavadinović, Lidija; Pelemis, Mijomir; Petrović, Svetlana; Vidmanić, Ana; Popović, Olga; Eremić, Natasa; Sparrow, Erin; Torelli, Guido; Socquet, Muriel; Holt, Renée; Ilieva-Borisova, Yordanka; Tang, Yuxiao; Scorza, Francesco Berlanda; Flores, Jorge; Rathi, Niraj

(SAGE Publications, 2020)

TY  - JOUR
AU  - Stevanović, Goran
AU  - Obradović, Aleksandar
AU  - Ristić, Snezana
AU  - Petrović, Dragan
AU  - Milenković, Branislava
AU  - Mitrović, Danilo
AU  - Vignjević Filipović, Svetlana
AU  - Ilić, Katarina
AU  - Stoiljković, Vera
AU  - Lavadinović, Lidija
AU  - Pelemis, Mijomir
AU  - Petrović, Svetlana
AU  - Vidmanić, Ana
AU  - Popović, Olga
AU  - Eremić, Natasa
AU  - Sparrow, Erin
AU  - Torelli, Guido
AU  - Socquet, Muriel
AU  - Holt, Renée
AU  - Ilieva-Borisova, Yordanka
AU  - Tang, Yuxiao
AU  - Scorza, Francesco Berlanda
AU  - Flores, Jorge
AU  - Rathi, Niraj
PY  - 2020
UR  - http://intor.torlakinstitut.com/handle/123456789/616
AB  - This 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
PB  - SAGE Publications
T2  - Therapeutic Advances in Vaccines and Immunotherapy
T1  - Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults
VL  - 8
DO  - 10.1177/2515135520925336
ER  - 
@article{
author = "Stevanović, Goran and Obradović, Aleksandar and Ristić, Snezana and Petrović, Dragan and Milenković, Branislava and Mitrović, Danilo and Vignjević Filipović, Svetlana and Ilić, Katarina and Stoiljković, Vera and Lavadinović, Lidija and Pelemis, Mijomir and Petrović, Svetlana and Vidmanić, Ana and Popović, Olga and Eremić, Natasa and Sparrow, Erin and Torelli, Guido and Socquet, Muriel and Holt, Renée and Ilieva-Borisova, Yordanka and Tang, Yuxiao and Scorza, Francesco Berlanda and Flores, Jorge and Rathi, Niraj",
year = "2020",
abstract = "This 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",
publisher = "SAGE Publications",
journal = "Therapeutic Advances in Vaccines and Immunotherapy",
title = "Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults",
volume = "8",
doi = "10.1177/2515135520925336"
}
Stevanović, G., Obradović, A., Ristić, S., Petrović, D., Milenković, B., Mitrović, D., Vignjević Filipović, S., Ilić, K., Stoiljković, V., Lavadinović, L., Pelemis, M., Petrović, S., Vidmanić, A., Popović, O., Eremić, N., Sparrow, E., Torelli, G., Socquet, M., Holt, R., Ilieva-Borisova, Y., Tang, Y., Scorza, F. B., Flores, J.,& Rathi, N.. (2020). Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults. in Therapeutic Advances in Vaccines and Immunotherapy
SAGE Publications., 8.
https://doi.org/10.1177/2515135520925336
Stevanović G, Obradović A, Ristić S, Petrović D, Milenković B, Mitrović D, Vignjević Filipović S, Ilić K, Stoiljković V, Lavadinović L, Pelemis M, Petrović S, Vidmanić A, Popović O, Eremić N, Sparrow E, Torelli G, Socquet M, Holt R, Ilieva-Borisova Y, Tang Y, Scorza FB, Flores J, Rathi N. Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults. in Therapeutic Advances in Vaccines and Immunotherapy. 2020;8.
doi:10.1177/2515135520925336 .
Stevanović, Goran, Obradović, Aleksandar, Ristić, Snezana, Petrović, Dragan, Milenković, Branislava, Mitrović, Danilo, Vignjević Filipović, Svetlana, Ilić, Katarina, Stoiljković, Vera, Lavadinović, Lidija, Pelemis, Mijomir, Petrović, Svetlana, Vidmanić, Ana, Popović, Olga, Eremić, Natasa, Sparrow, Erin, Torelli, Guido, Socquet, Muriel, Holt, Renée, Ilieva-Borisova, Yordanka, Tang, Yuxiao, Scorza, Francesco Berlanda, Flores, Jorge, Rathi, Niraj, "Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults" in Therapeutic Advances in Vaccines and Immunotherapy, 8 (2020),
https://doi.org/10.1177/2515135520925336 . .