[Safety and immunogenicity on three lots of influenza split vaccines among adults].
OBJECTIVE
To evaluate the immunogenicity, safety and stability of the manufacture process regarding three consecutive lots of influenza split vaccines (Anflu).


METHODS
A double-blind, randomized and controlled clinical trial was conducted in healthy volunteers. A total of 566 subjects aged 18 to 60 years were recruited and stratified into four age groups before randomly assigned into four groups. Each group would receive one dose of influenza vaccine from either one of the three lots of Anflu or one lot of the licensed control vaccine. Each dose of the vaccines contained 15 microg of each of the H1N1, H3N2 and B type antigen. Safety was assessed through 30-minute observation for immediate allergic reaction and three-day observation after vaccination. HI antibody titers were determined before vaccination and on day 21, after vaccination.


RESULTS
Mild adverse reaction was reported and the overall incidence rates on fever of the four groups were from 1.4% to 2.8% but no significant difference was observed between groups. Seroconversion rates of the three viral strains in four groups were 80.3% and above with fold increase as > or = 11.1 and protection rate was > or = 93.4%. For the three lots of investigated vaccines, all of the indexes of the three viral strains in four groups exceeded the standards on EMEA and FDA for influenza vaccine.


CONCLUSIONS
The three consecutive lots of Anflu appeared to be good, with both consistent immunogenicity and safety, indicating the stability of manufacture process.
Zhang
Zhi-Lun
ZL
Tianjin Center for Disease Control and Prevention, Tianjin, China.
Wang
Xu
X
Zhu
Xiang-Jun
XJ
Zhang
Ying
Y
Liu
Yan
Y
Gao
Zhi-Gang
ZG
Liang
Miao
M
Li
Lin
L
Li
Jia-Meng
JM
Liu
Rong-Kai
RK
Dong
Xiao-Jing
XJ
Song
Guang-Xin
GX
Zhang
Dao-Chang
DC
Wang
Wen-Quan
WQ
Han
Yong-Gang
YG
Chen
Jiang-Ting
JT
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000592:standards; D008875:Middle Aged; D019370:Observation; D012449:Safety; D055815:Young Adult
D000914:Antibodies, Viral; D007252:Influenza Vaccines