PMID- 37587615
OWN - NLM
STAT- MEDLINE
DCOM- 20230818
LR  - 20230828
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 19
IP  - 2
DP  - 2023 Aug 1
TI  - Immunogenicity and safety of the quadrivalent inactivated split-virion influenza 
      vaccine in populations aged >/= 3 years: A phase 3, randomized, double-blind, 
      non-inferiority clinical trial.
PG  - 2245721
LID - 10.1080/21645515.2023.2245721 [doi]
LID - 2245721
AB  - This study aimed to evaluate the immunogenicity non-inferiority and safety of the 
      quadrivalent inactivated split-virion influenza vaccine in participants >/= 3 years 
      old. A total of 3,328 participants were enrolled. Participants 3-8 years old were 
      administered one or two doses of the investigational vaccine or one dose of the 
      control vaccine, whereas the other participants were administered only one dose 
      of the investigational or control vaccine. The immunogenicity and occurrence of 
      adverse events (AEs) after 30 days of full-course vaccination and serious adverse 
      events (SAEs) within 6 months after full-course vaccination were assessed. The 
      sero-conversion rates (SCRs) of anti-H1N1, H3N2, B(Y), and B(V) antibodies in the 
      test group were 74.64%, 87.40%, 82.66%, and 78.89%, respectively, and their 
      geometric mean titers were 1:250.13, 1:394.54, 1:200.84, and 1:94.91, 
      respectively, which were non-inferior to those in the control group. The SCRs and 
      sero-protection rates in the two-dose group of participants 3-8 years old were 
      greater than those in the one-dose group. The incidences of total AEs and adverse 
      reactions in the test group were 31.6% and 21.7%, respectively, which were close 
      to those in the control group. In the two-dose group, the incidence of adverse 
      reactions was considerably lower in the second dose (5.5%) than in the first dose 
      (14.7%). Most AEs were grade 1 in severity, and no SAEs were recorded. The 
      investigational vaccine had immunogenicity non-inferior to the control vaccine, 
      and two doses were more effective than one dose in participants 3-8 years old, 
      with a good overall safety.Trial registration: CTR20200715.
FAU - Chen, Jianmin
AU  - Chen J
AUID- ORCID: 0009-0003-0464-2035
AD  - Economic and Technological Development Zone, Dalian Aleph Biomedical Co Ltd, 
      Dalian, China.
FAU - Jiang, Feng
AU  - Jiang F
AD  - Institute of Immunization Program, Guizhou Center for Disease Control and 
      Prevention, Guiyang, China.
FAU - Zhao, Chenyan
AU  - Zhao C
AD  - Division of HIV/AIDS and Sex-Transmitted Virus Vaccines, National Institutes for 
      Food and Drug Control (NIFDC), Beijing, China.
FAU - Chai, Jing
AU  - Chai J
AD  - Economic and Technological Development Zone, Dalian Aleph Biomedical Co Ltd, 
      Dalian, China.
FAU - Li, Lanshu
AU  - Li L
AD  - Division of HIV/AIDS and Sex-Transmitted Virus Vaccines, National Institutes for 
      Food and Drug Control (NIFDC), Beijing, China.
FAU - Guan, Qinghu
AU  - Guan Q
AD  - Institute of Immunization Program, Guizhou Center for Disease Control and 
      Prevention, Guiyang, China.
FAU - Li, Xiaoyu
AU  - Li X
AD  - Division of HIV/AIDS and Sex-Transmitted Virus Vaccines, National Institutes for 
      Food and Drug Control (NIFDC), Beijing, China.
FAU - Wang, Feiyu
AU  - Wang F
AUID- ORCID: 0009-0009-3901-6556
AD  - Economic and Technological Development Zone, Dalian Aleph Biomedical Co Ltd, 
      Dalian, China.
FAU - Li, Ansheng
AU  - Li A
AD  - Influenza Vaccine Production Workshop, Dalian Aleph Biomedical Co Ltd, Dalian, 
      China.
FAU - Gao, Hongxia
AU  - Gao H
AD  - Quality Control Department, Dalian Aleph Biomedical Co Ltd, Dalian, China.
FAU - Wang, Minghui
AU  - Wang M
AUID- ORCID: 0009-0009-5538-341X
AD  - Economic and Technological Development Zone, Dalian Aleph Biomedical Co Ltd, 
      Dalian, China.
FAU - Fu, Liandi
AU  - Fu L
AD  - Influenza Vaccine Production Workshop, Dalian Aleph Biomedical Co Ltd, Dalian, 
      China.
FAU - Nie, Fei
AU  - Nie F
AUID- ORCID: 0009-0003-2682-6935
AD  - Economic and Technological Development Zone, Dalian Aleph Biomedical Co Ltd, 
      Dalian, China.
FAU - Ling, Weijun
AU  - Ling W
AD  - Scientific Affairs Department, Simoon Record Beijing Co Ltd, Beijing, China.
FAU - Deng, Haobin
AU  - Deng H
AUID- ORCID: 0009-0009-5109-8726
AD  - Department of Bases Development, Simoon Record Beijing Co Ltd, Beijing, China.
FAU - Zhou, Lei
AU  - Zhou L
AUID- ORCID: 0009-0003-8402-0761
AD  - Economic and Technological Development Zone, Dalian Aleph Biomedical Co Ltd, 
      Dalian, China.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Child
MH  - Child, Preschool
MH  - Humans
MH  - Double-Blind Method
MH  - Influenza A Virus, H3N2 Subtype
MH  - *Influenza Vaccines/adverse effects/immunology
MH  - Vaccines, Combined
MH  - *Immunogenicity, Vaccine
PMC - PMC10438852
OAB - People in China are frequently infected by influenza viruses in specific seasons, 
      causing a large burden of disease. Influenza viruses have distinct phenotypes 
      depending on the season. Therefore, vaccines that can effectively prevent the 
      infection of various influenza virus phenotypes need to be developed. The 
      quadrivalent inactivated split-virion influenza vaccine is effective against four 
      influenza virus phenotypes. In this trial, the immunogenicity and safety of the 
      quadrivalent inactivated split-virion influenza vaccine (investigational vaccine) 
      developed by Dalian Aleph Biomedical Co., Ltd. were evaluated. A total of 3,328 
      participants >/= 3 years old were included. Participants 3-8 years old were further 
      divided based on the presence or absence of a history of influenza vaccination. 
      Those participants without a vaccination history were administered one or two 
      doses of the investigational vaccine or one dose of a marketed quadrivalent 
      influenza vaccine (control vaccine), and those participants with a vaccination 
      history were administered one dose of the investigational or control vaccine. 
      This study showed for the first time that the immunogenicity and safety of the 
      investigational vaccine were not inferior to those of the control vaccine and 
      that the two-dose procedure induced a good immune effect in the 3-8-year-old 
      group. In conclusion, administration of the investigational vaccine can prevent 
      seasonal influenza in populations aged >/= 3 years.
OABL- eng
OTO - NOTNLM
OT  - Quadrivalent inactivated split-virus influenza vaccine
OT  - immunogenicity
OT  - non-inferiority
OT  - populations >/= 3 years of age
OT  - safety
COIS- No potential conflict of interest was reported by the author(s).
EDAT- 2023/08/17 06:43
MHDA- 2023/08/18 06:42
PMCR- 2023/08/16
CRDT- 2023/08/17 00:33
PHST- 2023/08/18 06:42 [medline]
PHST- 2023/08/17 06:43 [pubmed]
PHST- 2023/08/17 00:33 [entrez]
PHST- 2023/08/16 00:00 [pmc-release]
AID - 2245721 [pii]
AID - 10.1080/21645515.2023.2245721 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2023 Aug 1;19(2):2245721. doi: 
      10.1080/21645515.2023.2245721.