PMID- 31070986
OWN - NLM
STAT- MEDLINE
DCOM- 20200514
LR  - 20200514
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 15
IP  - 12
DP  - 2019
TI  - A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the 
      safety and immunogenicity of a seasonal trivalent inactivated split-virion 
      influenza vaccine (IVACFLU-S) in healthy adults in Vietnam.
PG  - 2933-2939
LID - 10.1080/21645515.2019.1613127 [doi]
AB  - Background: Under the WHO's Global Action Plan for influenza vaccines, we 
      conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated 
      influenza vaccine candidate.Methods: In the phase 2 portion of the study, 252 
      participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or 
      placebo. Following determination of safety, 636 additional participants were 
      randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed 
      in a subset of the participants in the phase 3 study.Results: Higher proportion 
      (70%) of participants in the IVACFLU-S arm reported solicited local adverse 
      events (AEs) (p < .0001) as compared to placebo (25%). Mild injection site pain 
      and tenderness were most common AEs seen in 55% and 60% of participants in the 
      vaccine group. The solicited systemic AEs were comparable (p = .4149). The 
      majority of solicited and unsolicited AEs were mild to moderate in severity. In 
      the vaccine arm for the combined age group of 18-60 years of age, seroconversion 
      against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of 
      participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B 
      was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the 
      geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers 
      against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, 
      respectively.Conclusion: This study demonstrates the local reactogenicity, other 
      safety, and immunogenicity of IVACFLU-S, first domestically produced influenza 
      vaccine in Vietnam.ClinicalTrials.gov number NCT03095599 (March 29, 2017).
FAU - Lan, Phan Trong
AU  - Lan PT
AD  - Pasteur Institute, Ho Chi Minh City, Viet Nam.
FAU - Toan, Nguyen Trong
AU  - Toan NT
AD  - Pasteur Institute, Ho Chi Minh City, Viet Nam.
FAU - Thang, Hoang Anh
AU  - Thang HA
AD  - Pasteur Institute, Ho Chi Minh City, Viet Nam.
FAU - Thang, Tran Cong
AU  - Thang TC
AD  - PATH, Hanoi, Viet Nam.
FAU - Be, Le Van
AU  - Be LV
AD  - Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.
FAU - Thai, Duong Huu
AU  - Thai DH
AD  - Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.
FAU - Huong, Vu Minh
AU  - Huong VM
AD  - PATH, Hanoi, Viet Nam.
FAU - Nga, Nguyen Tuyet
AU  - Nga NT
AD  - PATH, Hanoi, Viet Nam.
FAU - Tang, Yuxiao
AU  - Tang Y
AD  - PATH, Seattle, WA, USA.
FAU - Holt, Renee
AU  - Holt R
AD  - PATH, Seattle, WA, USA.
FAU - Francesco, Berlanda Scorza
AU  - Francesco BS
AD  - PATH, Seattle, WA, USA.
FAU - Flores, Jorge
AU  - Flores J
AD  - PATH, Seattle, WA, USA.
FAU - Tewari, Tushar
AU  - Tewari T
AUID- ORCID: 0000-0001-5842-8622
AD  - PATH, Seattle, WA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03095599
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190620
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Antigens, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral/*blood
MH  - Antigens, Viral/immunology
MH  - Double-Blind Method
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Influenza A Virus, H1N1 Subtype
MH  - Influenza A Virus, H3N2 Subtype
MH  - Influenza Vaccines/adverse effects/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Seroconversion
MH  - Vaccines, Inactivated/immunology
MH  - Vietnam
MH  - Young Adult
PMC - PMC6930107
OTO - NOTNLM
OT  - Trivalent seasonal influenza vaccine
OT  - Vietnam
OT  - immunogenicity
OT  - safety
EDAT- 2019/05/10 06:00
MHDA- 2020/05/15 06:00
PMCR- 2019/06/20
CRDT- 2019/05/10 06:00
PHST- 2019/05/10 06:00 [pubmed]
PHST- 2020/05/15 06:00 [medline]
PHST- 2019/05/10 06:00 [entrez]
PHST- 2019/06/20 00:00 [pmc-release]
AID - 1613127 [pii]
AID - 10.1080/21645515.2019.1613127 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2019;15(12):2933-2939. doi: 10.1080/21645515.2019.1613127. 
      Epub 2019 Jun 20.