Safety evaluation of a quadrivalent split influenza vaccine

Abstract

Objective To evaluate muscular stimulation,acute toxicity and anaphylaxis of a quadrivalent split influenza vaccine for safety investigation.Methods Rabbits were intramuscularly administrated with the vaccine (0.5 ml,once daily for consecutive 2 d).Macrographic and pathological examinations of injection site were conducted 48 h and 16 d after the last administration.Mice were intramuscularly injected with the vaccine (0.2 ml) and observed continuously for 14 d for acute toxical symptoms.Guinea pigs were intramuscularly administrated with the vaccine (0.5 ml) every other day for 3 times and intravenously injected (1.0 ml) 14 and 21 d after the last sensitization,and then allergic reactions were observed within 30 min.Results The vaccine had no intramuscular irritation or injury effect on the injection site 48 h and 16 d after administration.All mice survived and no toxicological changes were observed in body weight,feed consumption,injection sites,appearance,behavioral activity,respiration,excretion,macroscopic examination of organs and tissues.No allergy symptoms occurred in guinea pigs after intravenous injection.Conclusion There is no intramuscular stimulation,acute toxicity and sensitization of the quadrivalent split influenza vaccine. Key words: Influenza vaccines; Intramuscular stimulation; Acute toxicity tests; Anaphylaxis