Influenza Clinical Trial
Official title:
A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Split Virion Influenza Vaccine in Healthy Thai Adults Aged Between 18 Years to 49 Years
The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.
This is a double blind randomized study consisting of two phases - Phase I and Phase II. The
same vaccine, a seasonal trivalent inactivated split virion influenza vaccine
[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant
virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains]
will be given in both Phase I and Phase II of the study.
The vaccine will be administered via the intramuscular route; the preferred injection site
will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the
clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total
follow-up is 90 days.
Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.
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