Safety and immunogenicity of influenza vaccine (split virion) in humans
10. 3760/cma. j. issn. 0254-5101. 2018. 05. 006
- VernacularTitle:流感病毒裂解疫苗接种人体后的安全性和免疫原性研究
- Author:
Xue GUO
1
;
Yanli MA
;
Yanxian KANG
;
Wei JIANG
;
Tao JIA
;
Xuanwen SHI
;
Peng DENG
;
Xuemei ZHANG
;
Qiong LI
;
Ye QIU
;
Xiao′ai QIAN
;
Haiping CHEN
;
Beifang YANG
Author Information
1. 130012,春生物制品研究所有限责任公司
- Keywords:
Influenza vaccine (split virion);
Safety;
Immunogenicity
- From:
Chinese Journal of Microbiology and Immunology
2018;38(5):361-365
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the immunogenicity and safety of a split-virion influenza vac-cine after its manufacturing process was improved. Methods The immunological non-inferiority of trial to control vaccines was evaluated in 240 subjects aged 3-<18 years. Another 360 subjects aged 18-<60 years were randomly divided into three groups that were respectively given three consecutive lots of trail vaccine to assess the consistency of immunogenicity. Results There were 4. 17% of the subjects aged 3-<18 years showed adverse reactions following immunization with trail vaccine and it was not significantly different from that of the control group (P>0. 05). No significant difference in seroconversion rate, geometric mean titer (GMT) of haemagglutination inhibition antibodies(HIAb) or protection rate was found between trial and control groups (P>0. 05). No significant difference in seroconversion rate or HIAb GMT was found among the three lots (P>0. 05). Conclusion The trial influenza vaccine has good safety, immunogenicity and lot-to-lot consistency after the manufacturing process was improved.
