A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.
This is a phase 3, double-blind, randomized, placebo- controlled trial with two groups of participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or placebo (phosphate buffered saline). A total of about 480 healthy male and female adults 18 through 65 years of age; 320 participants will be randomized to receive vaccine and160 will receive placebo (a 2:1 ratio). At least 25% of the participants (N=120) will be \>/= 45 years of age (80 vaccine and 40 placebo recipients). Safety will be assessed in all participants through Day 91. Immunogenicity will be assessed in serum samples obtained at baseline and 21 days after vaccination in a subset of at least 100 individuals randomized to study vaccine and 50 placebo recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
480
Clinical Center of Serbia: Clinic for Infectious and Tropical Diseases
Belgrade, Serbia
Clinical Center of Serbia: Clinic for Pulmonology
Belgrade, Serbia
Institute for Students' Healthcare
Belgrade, Serbia
Institute of Health Care of Workers of the Ministry of Internal Affairs
Belgrade, Serbia
Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity)
Number of participants experiencing one or more solicited local AEs, including redness /erythema, swelling / induration and pain
Time frame: 30-minute post-vaccination period
Number of Participants With Solicited Local Adverse Events (Local Reactogenicity)
Number of subjects reporting one or more solicited local reactions (redness/erythema, swelling/induration, pain, and tenderness) at the injection site post-vaccination with study vaccine or placebo
Time frame: 5-day period (Days 1-5) post-vaccination
Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity)
Number of subjects reporting one or more solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo.
Time frame: 5-day period (Days 1-5) post-vaccination
Number of Participants With Unsolicited Adverse Events
Unsolicited AEs occurring in 1% or more of study participants; includes events irrespective of causality
Time frame: Within 21 days post vaccination
Number of Participants With Serious Adverse Events (SAE)
Number of participants reporting one or more of all anticipated and unanticipated serious adverse events, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Time frame: Over the entire study period (Day 91)
Number and Percentage of Seroconverted Subjects
Seroconversion is defined as a serum HAI antibody titer meeting the following criteria: * Pre-vaccination titer \<1:10 and a post-vaccination titer measured on Day 22 of ≥1:40; or * Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 22. Measured against each of the 3 antigens
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Jevremova Special gynecology hospital with maternity
Belgrade, Serbia
General Hospital Vrsac
Vršac, Serbia
Time frame: Day 22
Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection)
Seroprotective Titers is considered as HAI antibody Titre ≥1:40; measured for each of the 3 antigens
Time frame: Day 1 and Day 22
Geometric Mean Titers (GMTs) of Serum HAI Antibodies
Serum HAI Antibodies GMTs Pre- (Day 1) and Post-vaccination (Day 22); measured for each of the 3 antigens
Time frame: Day 1 and Day 22
Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies
GMFR calculated as GMT for of Serum HAI Antibodies Post-vaccination/Pre-vaccination; measured for each of the 3 antigens
Time frame: Day 1 and Day 22