Preventive Avian Flu Clinical Trial
Official title:
Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
The purpose of this study is to evaluate safety and reactogenicity of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, in Thailand to previously healthy Thais.
It is a phase I randomized placebo controlled trial (vaccine and placebo ratio of 2:1). A
phase II study is planned to be conducted following review of results of this phase.
Phase I: It is a double blind randomized placebo controlled trial involving 24 participants
age 18-49 years (16 will receive vaccines and 8 will receive placebo). All will be admitted
in the isolation ward for 10-14 days after each immunization mainly for safety assessment.
Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133
(H5N2) will be given by intranasal route 21 days apart. Each group of 4 participants will be
immunized at a time at 30-60 mins interval. All participants will be followed 21 days after
each immunization. Total follow up is 60 day.
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