The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.
This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV. The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine. The study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * TAK-850 * Influenza HA vaccine All participants received one injection. This single center trial was conducted in Japan. The overall time to participate in this study was 22 days. Participants made multiple visits to the clinic, including a final visit 21 days after the vaccination for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
400
TAK-850 subcutaneous injection
Influenza HA vaccine subcutaneous injection
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) 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: Baseline and Day 22
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) 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: Days 1 and 22
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) 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: Days 1 and 22
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.
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Time frame: Baseline and Day 22
GMT of SRH Antibody Titer (Egg-Derived Antigen)
GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of \<10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Time frame: Baseline and Day 22
GMT of HI Antibody Titer (Vero-Derived Antigen)
GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Time frame: Baseline and Day 22
GMT of SRH Antibody Titer (Vero-Derived Antigen)
GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
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: 22 Days
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: 22 days
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: 22 Days