Aim: To study tolerability and safety of pandemic vaccines against influenza A/H1N1 "INFLUVIR" and "PANDEFLU" on limited group of volunteers during phase I clinical trial.
Materials and methods: Thirty healthy volunteers were participated in phase I clinical trial. Clinical and laboratory tests of volunteers randomized to 2 groups (20 persons received vaccine and 10 persons - placebo) were performed. "INFLUVIR" vaccine was administered by intranasal route. Volunteers were hospitalized and followed up for development of local and systemic adverse events during 7 days after vaccination. "PANDEFLU" was administered intramuscularly; vaccinees were followed for 7 days in outpatient settings. RESULTS. Phase I clinical trial showed good tolerability and low reactogenicity of "INFLUVIR" and "PANDEFLU" vaccines. There were no moderate and severe local and systemic adverse events registered.
Conclusion: On the basis of performed phase I clinical trial, phase II trial was recommended to perform in order to assess the reactogenicity, safety and immunogenicity of studied vaccines.