Avian Influenza Clinical Trial
Official title:
Evaluation of Priming Effects by Pandemic Live Attenuated Influenza Vaccine (LAIV Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2)) on the Subsequent Response to Inactivated H5N1 Vaccine in Healthy Thai Volunteers: A Non-Randomized, Open Label Study
This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects
It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine
(produced by Microgen Russia) which will be given to healthy adult volunteers who
participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU
Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty
of Tropical Medicine, Mahidol University in February to May 2013.
A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and
20 received placebo (control group) in the previous study will be asked to return to the
clinic to receive a single dose of an inactivated H5 influenza vaccine.
Total foloww up is 90 days.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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