The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
44
A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).
water for injection
Kazakh National Medical University
Almaty, Almaty, Kazakhstan
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: Two hours
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
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
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study 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
Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Three weeks of receipt
Geometric Mean Fold Increase in HI Antibody Titer
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Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Time frame: Change from Baseline HI Antibody Titer at 21 days
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
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 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 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 days after vaccination. Day 1 data is reported for reference.
Time frame: Change from Baseline HI Antibody Titer at 21 days