ABSTRACT
Objective To evaluate the safety of a Chinese thimerosal-free trivalent split influenza virus vaccine after being marketed in a large population. Methods Through the information management system of adverse event following immunization (AEFI), the adverse events in healthy people aged 6 months and above who were vaccinated with split influenza virus vaccine in Hubei Province from October to December 2015 were collected. The data was analyzed by descriptive methodology. Results From October 1, 2015 to June 30, 2016, among the 227 920 people in Hubei Province who were vaccinated with split influenza virus vaccine, the common adverse reactions were mainly fever, redness, irritability, pain and itching. Four cases of AEFI were passively observed and reported in the system, with a reporting rate of 1.76/100 000, among which 3 cases were anaphylactic rash and 1 case was optic neuritis. Conclusion The Chinese thimerosal-free trivalent split influenza virus vaccine used in Hubei Province had a good safety record and is suitable for the general vaccination of people without vaccination contraindications.
ABSTRACT
Objective To compare the safety and immunogenicity between domestic and imported,imported and imported split influenza virus vaccine in Chinese population. Methods The published studies during January 1996 and June 2008 on the comparison between split influenza virus vaccine were screened and evaluated.The meta analysis was performed on safety and immunogenicity using fixed model or random model according the heterogeneity of the studies. Results 12 studies which were all random controlled trials between split vaccine were included.10 trials were between domestic and imported vaccine,and 2 trials were between imported and imported vaccine.For 10 domestic and imported vaccine trials,the local reaction pooled OR=0.81,95% CI (0.59,1.11);the systemic reaction the pooled OR=0.78,95% CI (0.50,1.03);the H1N1 subtype seroconversion pooled OR= 0.94,95% CI (0.78,1.14);the H3N2 subtype seroconversion pooled OR =1.01,95% CI (0.87,1.17);the B type seroconversion total OR= 1.35,95% CI (0.98,1.85).For 2 imported and imported vaccine trials,the local reaction pooled OR = 1.19,95% CI (0.60,2.37);the systemic reaction the pooled OR =1.15,95% CI (0.71,1.87);the H1N1 subtype seroconversion pooled OR= 1.27,95% CI (0.37,4.37);the H3N2 subtype seroconversion pooled OR= 1.29,95% CI (0.39,4.33);the B type seroconversion pooled OR= 0.95,95% CI (0.46,1.37). Conclusions There were no statistical difference on the safety and immunogenicity between domestic and imported,imported and imported split influenza vaccine in Chinese population.
