Evaluation of immunogenicity and safety of two types of domestic novel influenza A(H1N1) vaccine

Objective To evaluate the immunog enicity and safety of two types of domesticlytic influenza A((H1N1) virus vaccine in humans.Methods Arandomized, double blind, controlled clinicaltrial was conducted in 748 healthy volunteers aged 3 years and older.The subjects were divided in to two trial groups and were inoculated with two different types of lytic vaccine(15 g hem agglutin in/agent) at 0 and 21 day, respectively.Safety was evaluated by observing adverse reaction after inoculation.Serumhem agg lutination inhibition(HI) antibody titers were tested at 0, 21 and 42 day to determine the irmimunog enicity.Results At 21 and 42 day a fter the inoculation, the positive seroconver sion rates of two different types of lytic vaccine were 81.39%, 92.01% and 94.05%, 95.80%.Antibody protective rates were 84.17%, 95.36% and 96.88%, 99.21%.The average increases of geometric meantiter in the two groups were 34.37, 55.34 times and 43.69, 57.20 tmies, respectively.Fever incidence rates of two groups were 9.44%, 14.69% and 4.53%, 2.36% after 30 minutes of inoculation.There were statistical significances in the indexes bewteen two groups except for positive sero conver sion rate and fever incidence rate at 42 day.Conclusion The two types of domesticlytic influenza A(H1N1) virus vaccine have good safety and mimuno genicity.