PMID- 34473607
OWN - NLM
STAT- MEDLINE
DCOM- 20220418
LR  - 20220418
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 18
IP  - 1
DP  - 2022 Dec 31
TI  - Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 
      years or above: a phase III randomized controlled clinical study.
PG  - 1-9
LID - 10.1080/21645515.2021.1967041 [doi]
AB  - To control seasonal influenza epidemics in elders, a quadrivalent, inactivated, 
      split-virion influenza vaccine (IIV4) comprising A and B lineages is produced for 
      young individuals and adults aged >/=60 years. In this phase III, randomized, 
      double-blind, active-controlled trial, we compared safety and immunogenicity of 
      IIV4 with a licensed quadrivalent inactivated vaccine (IIV4-HL) produced by 
      Hualan Biological Engineering during the 2019 influenza season. Participants were 
      randomly assigned to receive IIV4 (n = 959) or IIV4-HL (n = 959). Compared to 
      IIV4-HL, geometric mean titers (GMT) of hemagglutination inhibition (HAI) titers 
      and seroconversion rate (SCR) of IIV4 demonstrated better antibody responses in A 
      lineages (H1N1 and H3N2) (P < .01) and equivalent antibody responses in B 
      lineages (B/Yamagata and B/Victoria) (P > .01) in both age groups. After 
      immunization, IIV4 provided a satisfactory SCR and seroprotection rate (SPR) in 
      elders. No discernible variation in immunogenicity was observed between the two 
      age cohorts. In both age groups, IIV4 and IIV4-HL recipients experienced similar 
      levels of solicited and unsolicited adverse events (AEs), and the incidence of 
      AEs was low in both vaccine groups. Most AEs were of mild-to-moderate severity 
      and no grade 3 AEs in IIV4 group, but AEs in adults aged 60-65 were little higher 
      than in adults over 65 years in IIV4 and IIV4-HL groups (IIV4: 14.66% vs. 10.36%; 
      IIV4-HL:14.67% vs. 11.43%). Totally, IIV4 was generally well tolerated and 
      induced high antibody titers against all four influenza strains in elderly, 
      making it a compelling alternative for the elderly aged >/=60 years.Trial 
      registration: Clinical Trials.gov: 2015L00649-2.
FAU - Fan, Renfeng
AU  - Fan R
AD  - Guangdong Provincial Institute of Biological Products and Materia Medica, 
      Guangzhou, China.
FAU - Huang, Xiaoyuan
AU  - Huang X
AD  - Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
FAU - Nian, Xuanxuan
AU  - Nian X
AUID- ORCID: 0000-0002-6971-9916
AD  - Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
FAU - Ou, Zhiqiang
AU  - Ou Z
AD  - Guangdong Provincial Institute of Biological Products and Materia Medica, 
      Guangzhou, China.
FAU - Zhou, Jian
AU  - Zhou J
AD  - Gaozhou Center for Disease Control and Prevention, Gaozhou, China.
FAU - Zhang, Jiayou
AU  - Zhang J
AD  - Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
FAU - Zeng, Peiyu
AU  - Zeng P
AD  - Gaozhou Center for Disease Control and Prevention, Gaozhou, China.
FAU - Zhao, Wei
AU  - Zhao W
AD  - Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
FAU - Deng, Jinglong
AU  - Deng J
AD  - Gaozhou Center for Disease Control and Prevention, Gaozhou, China.
FAU - Chen, Wei
AU  - Chen W
AD  - Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
FAU - Chen, Shaomin
AU  - Chen S
AD  - Guangdong Provincial Institute of Biological Products and Materia Medica, 
      Guangzhou, China.
FAU - Duan, Kai
AU  - Duan K
AD  - Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
FAU - Chen, Yingshi
AU  - Chen Y
AD  - Guangdong Provincial Institute of Biological Products and Materia Medica, 
      Guangzhou, China.
FAU - Li, Xinguo
AU  - Li X
AD  - Wuhan Institute of Biological Products Co. Ltd, Wuhan, China.
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
FAU - Zhang, Jikai
AU  - Zhang J
AD  - Guangdong Provincial Institute of Biological Products and Materia Medica, 
      Guangzhou, China.
FAU - Yang, Xiaoming
AU  - Yang X
AUID- ORCID: 0000-0002-2481-555X
AD  - National Engineering Technology Research Center of Combined Vaccines, Wuhan, 
      China.
AD  - China National Biotec Group Company Limited, Beijing, China.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210902
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Viral
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - *Influenza A Virus, H1N1 Subtype
MH  - Influenza A Virus, H3N2 Subtype
MH  - *Influenza Vaccines
MH  - *Influenza, Human/prevention & control
MH  - Vaccines, Combined
MH  - Vaccines, Inactivated
PMC - PMC8920214
OTO - NOTNLM
OT  - Seasonal influenza
OT  - immunogenicity
OT  - quadrivalent
OT  - tolerability
OT  - vaccine
EDAT- 2021/09/03 06:00
MHDA- 2022/04/19 06:00
PMCR- 2021/09/02
CRDT- 2021/09/02 17:23
PHST- 2021/09/03 06:00 [pubmed]
PHST- 2022/04/19 06:00 [medline]
PHST- 2021/09/02 17:23 [entrez]
PHST- 2021/09/02 00:00 [pmc-release]
AID - 1967041 [pii]
AID - 10.1080/21645515.2021.1967041 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2022 Dec 31;18(1):1-9. doi: 10.1080/21645515.2021.1967041. 
      Epub 2021 Sep 2.