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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
945
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
Bangkok, Thailand
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination
Seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria. Pre-vaccination titer \<1:10 and a post-vaccination titer measured on Day 21 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 21. Measured against each of the 3 antigens
Time frame: pre-vaccination (Day 0), 21 days post-vaccination
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination
Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 21) for each of the three vaccine antigens. Note that titers below the lowest limit of quantitation (i.e., below the starting dilution of assay reported as "\< 10") will be set to half that limit (i.e., 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set to that limit.
Time frame: pre-vaccination (Day 0), 21 days post-vaccination
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination.
Solicited local and systemic adverse events within 30 minutes of vaccination and over the 3-day period post vaccination. Percentage of participants experiencing each reaction was calculated. Analysis based on Intention to Treat analysis
Time frame: 30-minutes period,day 1,day 2 and day 3 post-vaccination period
Number of Participants With Unsolicited Adverse Events.
Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated.
Time frame: within 90 days post-vaccination
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