TY  - DATA
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/123456789/637
AB  - Supplementary Table 1: Trial Scheme - Schedule of events for each participant; Supplementary Table 2: Details of Ethics committee/Institutional Review Board Overseeing  the study;
PB  - SAGE Publications
T2  - Therapeutic Advances in Vaccines and Immunotherapy
T1  - Supplementary information for the article: Stevanovic, G.; Obradovic, A.; Ristic, S.; Petrovic, D.; Milenkovic, B.; Mitrovic, D.; Vignjevic, S. F.;  Ilic, K.; Stoiljkovic, V.; Lavadinovic, L.; Pelemis, M.; Petrovic, S.; Vidmanic, A.; Popovic, O.; Eremic,  N.; Sparrow, E.; Torelli, G.; Socquet, M.; Holt, R.; Ilieva-Borisova, Y.; Tang, Y.; Scorza, F. B.; 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. Therapeutic Advances in Vaccines and Immunotherapy 2020, 8, 2515135520925336.  https://doi.org/10.1177/2515135520925336
VL  - 8
UR  - https://hdl.handle.net/21.15107/rcub_intor_637
ER  - 

@misc{
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 = "Supplementary Table 1: Trial Scheme - Schedule of events for each participant; Supplementary Table 2: Details of Ethics committee/Institutional Review Board Overseeing  the study;",
publisher = "SAGE Publications",
journal = "Therapeutic Advances in Vaccines and Immunotherapy",
title = "Supplementary information for the article: Stevanovic, G.; Obradovic, A.; Ristic, S.; Petrovic, D.; Milenkovic, B.; Mitrovic, D.; Vignjevic, S. F.;  Ilic, K.; Stoiljkovic, V.; Lavadinovic, L.; Pelemis, M.; Petrovic, S.; Vidmanic, A.; Popovic, O.; Eremic,  N.; Sparrow, E.; Torelli, G.; Socquet, M.; Holt, R.; Ilieva-Borisova, Y.; Tang, Y.; Scorza, F. B.; 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. Therapeutic Advances in Vaccines and Immunotherapy 2020, 8, 2515135520925336.  https://doi.org/10.1177/2515135520925336",
volume = "8",
url = "https://hdl.handle.net/21.15107/rcub_intor_637"
}

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). Supplementary information for the article: Stevanovic, G.; Obradovic, A.; Ristic, S.; Petrovic, D.; Milenkovic, B.; Mitrovic, D.; Vignjevic, S. F.;  Ilic, K.; Stoiljkovic, V.; Lavadinovic, L.; Pelemis, M.; Petrovic, S.; Vidmanic, A.; Popovic, O.; Eremic,  N.; Sparrow, E.; Torelli, G.; Socquet, M.; Holt, R.; Ilieva-Borisova, Y.; Tang, Y.; Scorza, F. B.; 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. Therapeutic Advances in Vaccines and Immunotherapy 2020, 8, 2515135520925336.  https://doi.org/10.1177/2515135520925336. in Therapeutic Advances in Vaccines and Immunotherapy
SAGE Publications., 8.
https://hdl.handle.net/21.15107/rcub_intor_637

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. Supplementary information for the article: Stevanovic, G.; Obradovic, A.; Ristic, S.; Petrovic, D.; Milenkovic, B.; Mitrovic, D.; Vignjevic, S. F.;  Ilic, K.; Stoiljkovic, V.; Lavadinovic, L.; Pelemis, M.; Petrovic, S.; Vidmanic, A.; Popovic, O.; Eremic,  N.; Sparrow, E.; Torelli, G.; Socquet, M.; Holt, R.; Ilieva-Borisova, Y.; Tang, Y.; Scorza, F. B.; 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. Therapeutic Advances in Vaccines and Immunotherapy 2020, 8, 2515135520925336.  https://doi.org/10.1177/2515135520925336. in Therapeutic Advances in Vaccines and Immunotherapy. 2020;8.
https://hdl.handle.net/21.15107/rcub_intor_637 .

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, "Supplementary information for the article: Stevanovic, G.; Obradovic, A.; Ristic, S.; Petrovic, D.; Milenkovic, B.; Mitrovic, D.; Vignjevic, S. F.;  Ilic, K.; Stoiljkovic, V.; Lavadinovic, L.; Pelemis, M.; Petrovic, S.; Vidmanic, A.; Popovic, O.; Eremic,  N.; Sparrow, E.; Torelli, G.; Socquet, M.; Holt, R.; Ilieva-Borisova, Y.; Tang, Y.; Scorza, F. B.; 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. Therapeutic Advances in Vaccines and Immunotherapy 2020, 8, 2515135520925336.  https://doi.org/10.1177/2515135520925336" in Therapeutic Advances in Vaccines and Immunotherapy, 8 (2020),
https://hdl.handle.net/21.15107/rcub_intor_637 .

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 . .

TY  - JOUR
AU  - Stevanović, Goran
AU  - Lavadinović, Lidija
AU  - Filipović-Vignjević, Svetlana
AU  - Holt, Renee
AU  - Ilić, Katarina
AU  - Scorza, Francesco Berlanda
AU  - Sparrow, Erin
AU  - Stoiljković, Vera
AU  - Torelli, Guido
AU  - Madenwald, Tamra
AU  - Socquet, Muriel
AU  - Barac, Aleksandra
AU  - Ilieva-Borisova, Yordanka
AU  - Pelemiš, Mijomir
AU  - Flores, Jorge
PY  - 2018
UR  - http://intor.torlakinstitut.com/handle/123456789/517
AB  - This study was a phase I double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a Serbian-produced seasonal trivalent split, inactivated influenza vaccine in healthy adults. The vaccine was manufactured in eggs by the Torlak Institute of Virology, Vaccines and Sera, Belgrade, Serbia and contained A/H1N1, A/H3N2 and B viruses. The clinical trial took place at the Clinical Center of Serbia in Belgrade. Sixty healthy volunteers, aged 18-45years, were enrolled in the trial. On the day of immunization, volunteers were randomly assigned to receive either a single dose of the trivalent seasonal influenza vaccine (15g of hemagglutinin per strain) or placebo (phosphate-buffered saline). Subjects were monitored for adverse events through a clinical history and physical examination, and blood was taken for testing at screening and on day 8 to assess vaccine safety. Serum samples obtained before and 21days after immunization were tested for influenza antibody titers using hemagglutination-inhibition (HAI) and microneutralization (MN) tests. No serious adverse events were reported. Pain and tenderness at the injection site were the most commonly reported symptoms in both vaccine and placebo groups. Overall, serum HAI responses of fourfold or greater magnitude were observed to H1, H3, and B antigen in 80%, 75%, and 70% of subjects, respectively. Seroprotection rates as measured by HAI were also high (100%, 100% and 86.67%, respectively, for H1, H3 and B). Thus, Torlak's seasonal trivalent influenza vaccine was not associated with adverse events, was well-tolerated and immunogenic. It should be further evaluated in clinical trials to provide sufficient safety and immunogenicity data for licensing in Serbia.
PB  - Taylor & Francis Inc, Philadelphia
T2  - Human Vaccines & Immunotherapeutics
T1  - Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults
EP  - 586
IS  - 3
SP  - 579
VL  - 14
DO  - 10.1080/21645515.2017.1415683
ER  - 

@article{
author = "Stevanović, Goran and Lavadinović, Lidija and Filipović-Vignjević, Svetlana and Holt, Renee and Ilić, Katarina and Scorza, Francesco Berlanda and Sparrow, Erin and Stoiljković, Vera and Torelli, Guido and Madenwald, Tamra and Socquet, Muriel and Barac, Aleksandra and Ilieva-Borisova, Yordanka and Pelemiš, Mijomir and Flores, Jorge",
year = "2018",
abstract = "This study was a phase I double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a Serbian-produced seasonal trivalent split, inactivated influenza vaccine in healthy adults. The vaccine was manufactured in eggs by the Torlak Institute of Virology, Vaccines and Sera, Belgrade, Serbia and contained A/H1N1, A/H3N2 and B viruses. The clinical trial took place at the Clinical Center of Serbia in Belgrade. Sixty healthy volunteers, aged 18-45years, were enrolled in the trial. On the day of immunization, volunteers were randomly assigned to receive either a single dose of the trivalent seasonal influenza vaccine (15g of hemagglutinin per strain) or placebo (phosphate-buffered saline). Subjects were monitored for adverse events through a clinical history and physical examination, and blood was taken for testing at screening and on day 8 to assess vaccine safety. Serum samples obtained before and 21days after immunization were tested for influenza antibody titers using hemagglutination-inhibition (HAI) and microneutralization (MN) tests. No serious adverse events were reported. Pain and tenderness at the injection site were the most commonly reported symptoms in both vaccine and placebo groups. Overall, serum HAI responses of fourfold or greater magnitude were observed to H1, H3, and B antigen in 80%, 75%, and 70% of subjects, respectively. Seroprotection rates as measured by HAI were also high (100%, 100% and 86.67%, respectively, for H1, H3 and B). Thus, Torlak's seasonal trivalent influenza vaccine was not associated with adverse events, was well-tolerated and immunogenic. It should be further evaluated in clinical trials to provide sufficient safety and immunogenicity data for licensing in Serbia.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Human Vaccines & Immunotherapeutics",
title = "Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults",
pages = "586-579",
number = "3",
volume = "14",
doi = "10.1080/21645515.2017.1415683"
}

Stevanović, G., Lavadinović, L., Filipović-Vignjević, S., Holt, R., Ilić, K., Scorza, F. B., Sparrow, E., Stoiljković, V., Torelli, G., Madenwald, T., Socquet, M., Barac, A., Ilieva-Borisova, Y., Pelemiš, M.,& Flores, J.. (2018). Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults. in Human Vaccines & Immunotherapeutics
Taylor & Francis Inc, Philadelphia., 14(3), 579-586.
https://doi.org/10.1080/21645515.2017.1415683

Stevanović G, Lavadinović L, Filipović-Vignjević S, Holt R, Ilić K, Scorza FB, Sparrow E, Stoiljković V, Torelli G, Madenwald T, Socquet M, Barac A, Ilieva-Borisova Y, Pelemiš M, Flores J. Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults. in Human Vaccines & Immunotherapeutics. 2018;14(3):579-586.
doi:10.1080/21645515.2017.1415683 .

Stevanović, Goran, Lavadinović, Lidija, Filipović-Vignjević, Svetlana, Holt, Renee, Ilić, Katarina, Scorza, Francesco Berlanda, Sparrow, Erin, Stoiljković, Vera, Torelli, Guido, Madenwald, Tamra, Socquet, Muriel, Barac, Aleksandra, Ilieva-Borisova, Yordanka, Pelemiš, Mijomir, Flores, Jorge, "Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults" in Human Vaccines & Immunotherapeutics, 14, no. 3 (2018):579-586,
https://doi.org/10.1080/21645515.2017.1415683 . .