The study is Multicenter, phase 3, Open-Label trial that explored the preventive effectiveness, safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
The study will include 2000 volunteers, 1,000 of whom will be vaccinated intramuscularly with a single dose of allantoic split inactivated seasonal influenza vaccine. All participants will be observed for 6 months to evaluate the effectiveness of the vaccine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
2,000
Allantoic split inactivated seasonal influenza vaccine
Research Institute for Biological Safety Problems
Gvardeysky, Zhambyl, Kazakhstan
Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers
An assessment of the incidence of influenza among vaccinated and unvaccinated volunteers will be conducted within 180 days of observation (PCR diagnostics for the detection of influenza viruses).
Time frame: 180 days
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
Time frame: 21 days
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Time frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
Serious adverse events (SAEs), including abnormal laboratory findings
Time frame: up to 24 weeks
Geometric Mean Fold Increase in HI Antibody Titer
1A group
Time frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
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1A group - Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21, 90, 180 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10.
Time frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days
Seroprotection Rate of HI Antibody Titer
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21, 90, 180 days after vaccination. Day 1 data is reported for reference.
Time frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days