PMID- 32518891
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2515-1355 (Print)
IS  - 2515-1363 (Electronic)
IS  - 2515-1355 (Linking)
VI  - 8
DP  - 2020
TI  - Safety and immunogenicity of a seasonal trivalent inactivated split influenza 
      vaccine: a double blind, phase III randomized clinical trial in healthy Serbian 
      adults.
PG  - 2515135520925336
LID - 10.1177/2515135520925336 [doi]
LID - 2515135520925336
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 microg 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.
CI  - (c) The Author(s), 2020.
FAU - Stevanovic, Goran
AU  - Stevanovic G
AD  - Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade 
      Faculty of Medicine, Belgrade, Serbia.
FAU - Obradovic, Aleksandar
AU  - Obradovic A
AD  - Jevremova Special gynecology hospital with maternity, Belgrade, Serbia.
FAU - Ristic, Snezana
AU  - Ristic S
AD  - Institute for Students' Healthcare, Belgrade, Serbia.
FAU - Petrovic, Dragan
AU  - Petrovic D
AD  - Institute of Health Care of Workers of the Ministry of Internal Affairs, 
      Belgrade, Serbia.
FAU - Milenkovic, Branislava
AU  - Milenkovic B
AD  - Clinical Center of Serbia, Clinic for Pulmonology, Belgrade, Serbia.
FAU - Mitrovic, Danilo
AU  - Mitrovic D
AD  - General Hospital Vrsac, Belgrade, Serbia.
FAU - Vignjevic, Svetlana Filipovic
AU  - Vignjevic SF
AD  - Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
FAU - Ilic, Katarina
AU  - Ilic K
AD  - Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
FAU - Stoiljkovic, Vera
AU  - Stoiljkovic V
AD  - Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
FAU - Lavadinovic, Lidija
AU  - Lavadinovic L
AD  - Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade 
      Faculty of Medicine, Belgrade, Serbia.
FAU - Pelemis, Mijomir
AU  - Pelemis M
AD  - Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade 
      Faculty of Medicine, Belgrade, Serbia.
FAU - Petrovic, Svetlana
AU  - Petrovic S
AD  - Institute for Students' Healthcare, Belgrade, Serbia.
FAU - Vidmanic, Ana
AU  - Vidmanic A
AD  - Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
FAU - Popovic, Olga
AU  - Popovic O
AD  - Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
FAU - Eremic, Natasa
AU  - Eremic N
AD  - Institute of Virology, Vaccines and Sera "Torlak", Belgrade, Serbia.
FAU - Sparrow, Erin
AU  - Sparrow E
AD  - The World Health Organization, Geneva, Switzerland.
FAU - Torelli, Guido
AU  - Torelli G
AD  - The World Health Organization, Geneva, Switzerland.
FAU - Socquet, Muriel
AU  - Socquet M
AD  - PATH Switzerland, Geneva, Switzerland.
FAU - Holt, Renee
AU  - Holt R
AD  - PATH US, Seattle, WA, USA.
FAU - Ilieva-Borisova, Yordanka
AU  - Ilieva-Borisova Y
AD  - PATH US, Washington DC, USA.
FAU - Tang, Yuxiao
AU  - Tang Y
AD  - PATH US, Seattle, WA, USA.
FAU - Scorza, Francesco Berlanda
AU  - Scorza FB
AD  - PATH US, Washington DC, USA.
FAU - Flores, Jorge
AU  - Flores J
AD  - PATH US, Washington DC, USA.
FAU - Rathi, Niraj
AU  - Rathi N
AUID- ORCID: 0000-0002-5560-5504
AD  - PATH India, 15th Floor, Dr Gopal Das Bhawan, 28, Barakhamba Road, Connaught 
      Place, New Delhi, Delhi 110001, India.
LA  - eng
SI  - ClinicalTrials.gov/NCT02935192
PT  - Journal Article
DEP - 20200525
PL  - England
TA  - Ther Adv Vaccines Immunother
JT  - Therapeutic advances in vaccines and immunotherapy
JID - 101718382
PMC - PMC7252356
OTO - NOTNLM
OT  - Serbia
OT  - Torlak
OT  - clinical trial
OT  - seasonal influenza vaccine
OT  - trivalent inactivated split
COIS- Conflict of interest statement: The authors declare that there is no conflict of 
      interest.
EDAT- 2020/06/11 06:00
MHDA- 2020/06/11 06:01
PMCR- 2020/05/25
CRDT- 2020/06/11 06:00
PHST- 2019/04/08 00:00 [received]
PHST- 2020/02/12 00:00 [accepted]
PHST- 2020/06/11 06:00 [entrez]
PHST- 2020/06/11 06:00 [pubmed]
PHST- 2020/06/11 06:01 [medline]
PHST- 2020/05/25 00:00 [pmc-release]
AID - 10.1177_2515135520925336 [pii]
AID - 10.1177/2515135520925336 [doi]
PST - epublish
SO  - Ther Adv Vaccines Immunother. 2020 May 25;8:2515135520925336. doi: 
      10.1177/2515135520925336. eCollection 2020.