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CompletedNCT02555618Updated Dec 29, 2016Results posted

Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants

A Phase 2 interventional study of TAK-850 and Influenza HA vaccine in Influenza Infection, sponsored by Takeda. Completed. Open to participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-29.

Sponsored by Takeda · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
20 Years to 49 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Influenza Infection

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Keywords

  • Vaccine
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 400 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
  3. The participant is a healthy Japanese adult male or female.
  4. The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
  5. The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m\^2, inclusive, at the time of the eligibility evaluation.
  6. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agreed to routinely use adequate contraception from signing of the informed consent throughout the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. The participant has received any investigational compound within 4 months prior to injection of study vaccine.
  2. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to injection of study vaccine.
  3. The participant has a history of influenza infection within 6 months prior to injection of study vaccine.
  4. The participant has been vaccinated with TAK-850 before.
  5. The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
  6. The participant has uncontrolled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine, or other disorders, which may impact the ability of the participant to participate or potentially confound the study results.
  7. The participant has an oral temperature >= 37.5 °C prior to injection of study vaccine on Day 1.
  8. The participant has any medically diagnosed or suspected immune deficient condition.
  9. The participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to injection of study vaccine. Such treatments include systemic or high dose inhaled corticosteroids (> 800 µg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation therapy, and other immunosuppressive and cytotoxic drugs.
  10. The participant has received antipyretics within 4 hours prior to the injection of study vaccine.
  11. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis), or convulsions.
  12. The participant has a functional or surgical asplenia.
  13. The participant has a rash, other dermatologic conditions, or tattoos which may interfere with the evaluation of injection site reaction.
  14. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
  15. The participant has known hypersensitivity to any component of TAK-850 or Influenza HA Vaccine.
  16. The participant has a history of severe allergic reactions or anaphylaxis.
  17. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to injection of study vaccine or is unwilling to agree to abstain from excessive alcohol and drugs throughout the study.
  18. The participant has received any blood products (blood transfusion or immunoglobulin) within 90 days prior to injection of study vaccine.
  19. The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to injection of study vaccine.
  20. If female, the participant is pregnant or lactating or intending to become pregnant before signing of informed consent, during treatment, or within 12 weeks after injection of study vaccine; or intending to donate ova during this time period.
  21. The participant has donated whole blood >= 200 mL within 4 weeks (28 days), >= 400 mL within 12 weeks (84 days), >= 800 mL within 52 weeks (364 days) or blood components within 2 weeks (14 days) prior to injection of study vaccine.
  22. The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the injection of study vaccine, or the participant has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the respective upper limits of normal.
  23. In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reasons.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    TAK-850

    A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.

    Biological: TAK-850

  • Active comparator
    Influenza HA Vaccine

    A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.

    Biological: Influenza HA vaccine

Interventions

  • BiologicalTAK-850

    TAK-850 subcutaneous injection

  • BiologicalInfluenza HA vaccine

    Influenza HA vaccine subcutaneous injection

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

    Time frame: Baseline and Day 22

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

07

Results

Posted Dec 29, 2016

Participant flow

Participants took part in the study at 1 investigative site in Japan from 24 September 2015 to 18 November 2015.

Participant flow — Overall Study
MilestoneTAK-850Influenza HA Vaccine
Started200200
Completed199200
Not completed10
Withdrew: Sponsor's circumstances10

Outcome measures

PrimarySeroconversion 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
Reported as:
Number · percentage of participants
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain47.7 (40.627 to 54.918)46.0 (38.948 to 53.172)
A/H3N2 Strain31.2 (24.795 to 38.088)36.0 (29.350 to 43.071)
B Strain28.6 (22.472 to 35.463)26.0 (20.068 to 32.658)
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Rate difference: 1.7 · 95% CI -7.983 to 11.415TAK-850 - Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Rate difference: -4.8 · 95% CI -13.974 to 4.403TAK-850 - Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Rate difference: 2.6 · 95% CI -6.082 to 11.320TAK-850 - Influenza HA Vaccine
PrimaryGeometric 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
Reported as:
Geometric mean · titer
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
titerTAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 139.04 ± 5.25643.77 ± 4.794
A/H1N1 Strain-Day 22239.24 ± 3.098241.88 ± 2.839
A/H3N2 Strain-Day 121.39 ± 4.55822.62 ± 4.823
A/H3N2 Strain-Day 2264.80 ± 4.64384.93 ± 5.496
B Strain-Day 124.65 ± 3.89825.34 ± 4.211
B Strain-Day 2270.14 ± 3.65265.89 ± 4.197
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 0.99 · 95% CI 0.7984 to 1.2253TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 0.76 · 95% CI 0.5544 to 1.0500TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 1.06 · 95% CI 0.8134 to 1.3931TAK-850/Influenza HA Vaccine
SecondarySeroprotection 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
Reported as:
Number · percentage of participants
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 162.8 (55.697 to 69.543)67.5 (60.535 to 73.937)
A/H1N1 Strain-Day 2295.5 (91.589 to 97.911)97.0 (93.585 to 98.891)
A/H3N2 Strain-Day 146.7 (39.645 to 53.921)47.5 (40.412 to 54.663)
A/H3N2 Strain-Day 2277.9 (71.477 to 83.451)78.0 (71.614 to 83.536)
B Strain-Day 153.3 (46.079 to 60.355)51.0 (43.852 to 58.118)
B Strain-Day 2281.4 (75.295 to 86.558)76.0 (69.469 to 81.743)
SecondaryGeometric 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
Reported as:
Geometric mean · fold increase
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
fold increaseTAK-850Influenza HA Vaccine
A/H1N1 Strain6.13 ± 5.4965.53 ± 5.353
A/H3N2 Strain3.03 ± 4.2683.75 ± 4.861
B Strain2.85 ± 3.3992.60 ± 3.356
SecondarySeroconversion 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.

Time frame:
Baseline and Day 22
Reported as:
Number · percentage of participants
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain50.8 (43.591 to 57.894)44.0 (37.006 to 51.175)
A/H3N2 Strain38.7 (31.890 to 45.839)47.5 (40.412 to 54.663)
B Strain31.7 (25.262 to 38.611)34.0 (27.467 to 41.016)
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Rate difference: 6.8 · 95% CI -3.020 to 16.348
  • TAK-850 vs Influenza HA Vaccine · Rate difference: -8.8 · 95% CI -18.282 to 0.901
  • TAK-850 vs Influenza HA Vaccine · Rate difference: -2.3 · 95% CI -11.461 to 6.835
SecondaryGMT 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
Reported as:
Geometric mean · mm^2
GMT of SRH Antibody Titer (Egg-Derived Antigen)
mm^2TAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 132.4939 ± 2.9886133.7752 ± 2.85080
A/H1N1 Strain-Day 2283.6792 ± 1.7039879.9046 ± 1.46596
A/H3N2 Strain-Day 123.6364 ± 2.9986624.8424 ± 2.79368
A/H3N2 Strain-Day 2248.0742 ± 2.0384853.5757 ± 1.87521
B Strain-Day 145.6214 ± 2.0006446.3984 ± 1.89520
B Strain-Day 2274.3848 ± 1.3253775.8772 ± 1.32751
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 1.05 · 95% CI 0.9559 to 1.1473TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 0.90 · 95% CI 0.7862 to 1.0241TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 0.98 · 95% CI 0.9273 to 1.0364TAK-850/Influenza HA Vaccine
SecondarySeroprotection 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
Reported as:
Number · percentage of participants
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 170.4 (63.484 to 76.601)73.0 (66.285 to 79.020)
A/H1N1 Strain-Day 2297.0 (93.553 to 98.886)98.5 (95.679 to 99.690)
A/H3N2 Strain-Day 163.8 (56.725 to 70.495)67.0 (60.017 to 73.470)
A/H3N2 Strain-Day 2289.4 (84.322 to 93.348)93.5 (89.141 to 96.494)
B Strain-Day 187.9 (82.588 to 92.118)88.5 (83.245 to 92.569)
B Strain-Day 2299.5 (97.232 to 99.987)99.0 (96.435 to 99.879)
SecondaryGeometric 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
Reported as:
Geometric mean · fold increase
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
fold increaseTAK-850Influenza HA Vaccine
A/H1N1 Strain2.5752 ± 2.836022.3658 ± 2.88645
A/H3N2 Strain2.0339 ± 2.547802.1566 ± 2.44635
B Strain1.6305 ± 1.816141.6353 ± 1.77973
SecondarySeroconversion 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
Reported as:
Number · percentage of participants
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain40.2 (33.330 to 47.369)25.5 (19.614 to 32.128)
A/H3N2 Strain27.1 (21.090 to 33.877)29.0 (22.816 to 35.819)
B Strain19.6 (14.323 to 25.803)22.0 (16.464 to 28.386)
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Rate difference: 14.7 · 95% CI 5.489 to 23.577
  • TAK-850 vs Influenza HA Vaccine · Rate difference: -1.9 · 95% CI -10.614 to 6.928
  • TAK-850 vs Influenza HA Vaccine · Rate difference: -2.4 · 95% CI -10.346 to 5.579
SecondaryGMT 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
Reported as:
Geometric mean · titer
GMT of HI Antibody Titer (Vero-Derived Antigen)
titerTAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 17.41 ± 2.3957.74 ± 2.346
A/H1N1 Strain-Day 2225.88 ± 4.29717.44 ± 3.978
A/H3N2 Strain-Day 115.93 ± 3.54914.67 ± 3.722
A/H3N2 Strain-Day 2239.65 ± 4.44937.19 ± 5.313
B Strain-Day 110.74 ± 2.82610.13 ± 2.721
B Strain-Day 2221.65 ± 4.00420.30 ± 3.770
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 1.48 · 95% CI 1.1221 to 1.9623TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 1.07 · 95% CI 0.7806 to 1.4564TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 1.07 · 95% CI 0.8166 to 1.3934TAK-850/Influenza HA Vaccine
SecondarySeroprotection 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
Reported as:
Number · percentage of participants
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 112.6 (8.298 to 17.984)11.0 (7.023 to 16.180)
A/H1N1 Strain-Day 2254.3 (47.079 to 61.334)40.0 (33.155 to 47.146)
A/H3N2 Strain-Day 138.7 (31.890 to 45.839)32.0 (25.596 to 38.947)
A/H3N2 Strain-Day 2266.8 (59.827 to 73.331)60.0 (52.854 to 66.845)
B Strain-Day 119.6 (14.323 to 25.803)22.0 (16.464 to 28.386)
B Strain-Day2243.2 (36.230 to 50.408)46.0 (38.948 to 53.172)
SecondaryGeometric 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
Reported as:
Geometric mean · fold increase
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
fold increaseTAK-850Influenza HA Vaccine
A/H1N1 Strain3.50 ± 4.0662.25 ± 3.539
A/H3N2 Strain2.49 ± 3.5842.54 ± 3.593
B Strain2.02 ± 3.0462.00 ± 2.831
SecondarySeroconversion 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
Reported as:
Number · percentage of participants
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain24.1 (18.352 to 30.677)23.0 (17.358 to 29.461)
A/H3N2 Strain41.2 (34.294 to 48.385)42.0 (35.074 to 49.166)
B Strain43.2 (36.230 to 50.408)40.0 (33.155 to 47.146)
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Rate difference: 1.1 · 95% CI -7.195 to 9.423TAK-850 - Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Rate difference: -0.8 · 95% CI -10.369 to 8.803TAK-850 - Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Rate difference: 3.2 · 95% CI -6.406 to 12.757TAK-850 - Influenza HA Vaccine
SecondaryGMT 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
Reported as:
Geometric mean · titer
GMT of SRH Antibody Titer (Vero-Derived Antigen)
titerTAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 17.4041 ± 2.324287.7958 ± 2.26942
A/H1N1 Strain-Day 2216.2670 ± 2.1327615.2566 ± 2.32297
A/H3N2 Strain-Day 119.7055 ± 2.0703319.1990 ± 2.14468
A/H3N2 Strain-Day 2232.4796 ± 1.7623433.2751 ± 1.85480
B Strain-Day 128.2050 ± 2.1796328.2142 ± 2.23368
B Strain-Day 2252.1647 ± 1.5382249.7468 ± 1.55670
Statistical analysis
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 1.07 · 95% CI 0.9106 to 1.2484TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 0.98 · 95% CI 0.8686 to 1.0969TAK-850/Influenza HA Vaccine
  • TAK-850 vs Influenza HA Vaccine · Ratio of gmts: 1.05 · 95% CI 0.9622 to 1.1427TAK-850/Influenza HA Vaccine
SecondarySeroprotection 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
Reported as:
Number · percentage of participants
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
percentage of participantsTAK-850Influenza HA Vaccine
A/H1N1 Strain-Day 117.1 (12.132 to 23.048)13.0 (8.671 to 18.465)
A/H1N1 Strain-Day 2233.7 (27.140 to 40.692)33.0 (26.530 to 39.983)
A/H3N2 Strain-Day 138.2 (31.411 to 45.328)42.5 (35.556 to 49.670)
A/H3N2 Strain-Day 2271.9 (65.065 to 77.990)74.0 (67.342 to 79.932)
B Strain-Day 165.3 (58.272 to 71.917)65.5 (58.469 to 72.063)
B Strain-Day 2292.5 (87.872 to 95.720)93.5 (89.141 to 96.494)
SecondaryGeometric 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
Reported as:
Geometric mean · fold increase
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
fold increaseTAK-850Influenza HA Vaccine
A/H1N1 Strain2.1970 ± 2.036851.9570 ± 2.16354
A/H3N2 Strain1.6483 ± 1.712981.7332 ± 1.71960
B Strain1.8495 ± 1.915831.7632 ± 2.03032
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
percentage of participantsTAK-850Influenza HA Vaccine
Injection site pain34.039.5
Injection site redness23.528.0
Injection site swelling15.520.0
Injection site induration7.010.0
Injection site ecchymosis3.54.5
Pyrexia0.00.5
Malaise10.511.0
Chills2.54.5
Fatigue10.56.5
Headache7.09.0
Sweaty0.51.5
Myalgia3.55.5
Arthralgia0.01.5
Nausea1.52.0
Vomiting0.51.0
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
percentage of participantsTAK-850Influenza HA Vaccine
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)62.064.0
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
percentage of participantsTAK-850Influenza HA Vaccine
Blood creatine phosphokinase increased2.01.0
Protein urine present0.50.5
Blood bilirubin increased0.50.0
Liver function test abnormal0.50.0
White blood cell count increased0.50.0
Alanine aminotransferase increased0.00.5
Blood glucose increased0.00.5

Adverse events

Collected over 22 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAK-850—0/200 (0%)117/200 (58.5%)
Influenza HA Vaccine—0/200 (0%)122/200 (61%)
Most frequent other events
Most frequent other events
EventTAK-850Influenza HA Vaccine
Injection site painGeneral disorders68/20079/200
Injection site erythemaGeneral disorders47/20056/200
Injection site swellingGeneral disorders31/20040/200
Injection site pruritusGeneral disorders19/20031/200
Injection site warmthGeneral disorders17/20029/200
MalaiseGeneral disorders21/20022/200
FatigueGeneral disorders21/20013/200
Injection site indurationGeneral disorders14/20020/200
HeadacheNervous system disorders14/20018/200
MyalgiaMusculoskeletal and connective tissue disorders7/20011/200

Baseline characteristics

Randomized Set included all randomized participants.

Age, Continuous
Age, Continuous(years)TAK-850Influenza HA VaccineTotal
Mean31.2 ± 9.6131.5 ± 9.4631.4 ± 9.52
Age, Customized
Age, Customized(participants)TAK-850Influenza HA VaccineTotal
20 to 29 years10298200
30 to 39 years464793
40 to 49 years5255107
Gender
Gender(Participants)TAK-850Influenza HA VaccineTotal
Female9495189
Male106105211
Region of Enrollment
Region of Enrollment(participants)TAK-850Influenza HA VaccineTotal
Japan200200400
Height
Height(cm)TAK-850Influenza HA VaccineTotal
Mean166.3 ± 8.41166.0 ± 8.32166.2 ± 8.35
Weight
Weight(kg)TAK-850Influenza HA VaccineTotal
Mean58.67 ± 8.91857.69 ± 7.93758.18 ± 8.445
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)TAK-850Influenza HA VaccineTotal
Mean21.10 ± 1.91220.86 ± 1.75220.98 ± 1.835
Influenza Infection within 1 Year
Influenza Infection within 1 Year(participants)TAK-850Influenza HA VaccineTotal
Yes141125
No186189375

3 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02555618
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Sep 21, 2015
Start date
Sep 2015
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Dec 29, 2016
Last update
Dec 29, 2016

Study contacts

Medical Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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