Influenza Due to Influenza A Virus Subtype H5N2 Clinical Trial
Official title:
Phase II 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 immune response and safety of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, Thailand in healthy Thais.
It is a double blind randomized study using 7.5-8.5 log EID50 dose which is the same dose as
being tested in phase I.
150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enrolled. All
will be separated in 4 batches; Batch 1: 36 participants (24 vaccinees and 12 placebos) Batch
2: 38 participants (25 vaccinees and 13 placebos) Batch 3: 38 participants (25 vaccinees and
13 placebos) Batch 4: 38 participants (26 vaccinees and 12 placebos)
Each batch will be admitted in the isolation ward for 5 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 28 days apart. Total
follow up is 60 day.
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