Evaluation on safety of domestic pandemic influenza vaccine among healthy adults in phase I clinical trials

Objective To conduct a phase Ⅰ clinical trial for pandemic influenza split-virion vaccine H5N1 and to assess the safety of the vaccine.Methods We conducted a single center,stratified-random,double-blind,placebo-controlled trial involving healthy adults aged 16 to 60 years who were assigned in a 1:1:1:1 ratio to receive two doses schedule(administered on days 0 and 21) of placebo(n=33) or an inactivated split-virion influenza A(H5N1) vaccine with 7.50 μg(n=33),15.0 μg(n=33),30.0 μg(n=33).Results In the stage of clinical trial and follow-up,no abnormal reaction,coupling reaction and any clinical significant serious adverse event was reported.Most of the reactions in all vaccine formulations were Ⅰ grade local reactions recovered within 48 hours.Reactions in treatment group were significantly higher than that of in placebo control group(χ 2=25.2825,P0.0001).The local and the systemic reaction rate of the group with 30.0 μg dose was the highest(78.79% and 51.52%).Reaction rate was 100% higher for the first dose than that of the second.Conclusion Pandemic influenza split-virion vaccine had better security,no grade Ⅲ and above of adverse reaction occured.