Influenza Clinical Trial
Official title:
A Phase II/III Double Blinded, Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Subjects Aged 18-49 Years
The study is aim to evaluate the immunogenicity and safety with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine
This is a phase II/III, non-inferiority double-blinded, randomized, controlled trial of
immunogenicity and safety with two groups of participants who will received a seasonal
trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator
(licensed influenza vaccine).
A total of about 945 healthy Thai male and female adult volunteers 18 through 49 years of
age; 630 participants will be randomized to receive the GPO Tri Fluvac and 315 will receive
an active comparator (a 2:1 ratio) (inclusion of ~7% lost to follow-up).
Safety will be assessed for all participants through Day 90 after vaccination. Immunogenicity
will be assessed in serum samples obtained at baseline and 21 days after vaccination in a
subset of at least 586 individuals randomized to study vaccine and 293 active comparator
vaccine recipients.
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