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Influenza PreventionPhase 2NCT02713061

A Phase 2 Study of a Subcutaneous Injection of TAK-850 in Healthy Adult Participants

A Phase 2 study testing TAK-850 in people with Influenza Prevention, run by Takeda at 1 site in Japan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22 days in healthy Japanese adults. Read more about this study

Who is it for?
Ages 20 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza Prevention
What is being tested?
TAK-850
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteJapan
Study dates
Mar 2016to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • The participant has received any investigational compound within 4 months prior to the initial injection of study vaccine.
  • The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the initial injection of study vaccine.
  • The participant has a history of influenza infection within 6 months prior to the initial injection of study vaccine
  • The participant has been vaccinated with TAK-850 (trivalent).
  • 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.
  • 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.
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  • The participant has an oral temperature ≥37.5°C prior to the initial injection of study vaccine on Day 1.
  • The participant has any medically diagnosed or suspected immune deficient condition.
  • 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 the initial injection of study vaccine. Such treatments include, but is not limited to, 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 treatment or other immunosuppressive or cytotoxic drugs.
  • The participant has received antipyretics within 4 hours prior to the initial injection of study vaccine.
  • The participant has a history of Guillain- Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis) or convulsions.
  • The participant has a functional or surgical asplenia.
  • The participant has a rash, other dermatologic conditions or tattoos which may interfere with the evaluation of injection site reaction as determined by the Investigator.
  • The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
  • The participant has a known hypersensitivity to any component of TAK-850.
  • The participant has a history of severe allergic reactions or anaphylaxis.
  • 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 the initial injection of study vaccine or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  • The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the initial injection of study vaccine.
  • The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to the initial injection of study vaccine.
  • If female, the participant is pregnant or lactating or intending to become pregnant before signing informed consent, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  • 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 the initial injection of study vaccine.
  • The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the initial injection of study vaccine, or the participant has the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the upper limits of normal.
  • In the opinion of the investigator or sub-investigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Toshima-ku, Tokyo

Other trials in Japan

About this study

Official title: An Open-label Phase 2 Study to Evaluate the Safety and Immnogenicity of a Single Subcutaneous Injection of Quadrivalent TAK-850 in Healthy Adult Subjects

This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22 days in healthy Japanese adults.

Read the detailed description

The primary objective of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 for 22 days in healthy Japanese adults.

Being tested
TAK-850

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-850Drug

    TAK-850 injection

Study groups in NCT02713061
Study groupRoleWhat they receive
TAK-850 0.5 mLExperimentalTAK-850 0.5 mL (15 µg of hemagglutinin [HA] antigen per strain), subcutaneous injection, once on Day 1.
Receives: Drug: TAK-850

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment The adverse events will include solicited local and systemic AEs.

    Measured: Up to Day 22

  2. Seroprotection Rate of Hemagglutination Inhibition (HI) Antibody Titer (egg-derived antigen)

    Seroprotection Rate is defined as the percentage of participants with HI antibody titer ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  3. Seroconversion Rate of HI Antibody Titer (egg-derived antigen)

    Seroconversion Rate is defined as the percentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  4. Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (egg-derived antigen)

    Measured: Day 22

Secondary outcomes (15)

  1. Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements

    Vital signs will include blood pressure, pulse rate and respiratory rate.

    Measured: Day 22

  2. Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests

    Laboratory tests will include hematology, biochemistry and urinalysis tests.

    Measured: Day 22

  3. Geometric Mean Titer (GMT) of HI Antibody Titer (egg-derived antigen)

    Measured: Day 22

  4. Seroprotection Rate of Single Radial Hemolysis (SRH) Antibody Titer (egg-derived antigen)

    Seroprotection Rate is defined as the percentage of participants with SRH antibody titer ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  5. Seroconversion Rate of SRH Antibody Titer (egg-derived antigen)

    Seroconversion Rate is defined as the percentage of participants with a baseline SRH antibody titer of ≥ 4 mm^2 achieving a minimal 50 percent increase, or baseline HI antibody titer of < 4 mm^2 achieving an SRH antibody titer of ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  6. GMFI in SRH Antibody Titer (egg-derived antigen)

    Measured: Day 22

  7. GMT of SRH Antibody Titer (egg-derived antigen)

    Measured: Day 22

  8. Seroprotection Rate of HI Antibody Titer (cell-derived antigen)

    Seroprotection Rate is defined as the percentage of participants with HI antibody titer ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  9. Seroconversion Rate of HI Antibody Titer (cell-derived antigen)

    Seroconversion Rate is defined as the percentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  10. GMFI in HI Antibody Titer (cell-derived antigen)

    Measured: Day 22

  11. GMT of HI Antibody Titer (cell-derived antigen)

    GMT of HI antibody titer for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain), 21 days after vaccination.

    Measured: Day 22

  12. Seroprotection Rate of SRH Antibody Titer (cell-derived antigen)

    Seroprotection Rate is defined as the percentage of participants with SRH antibody titer ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  13. Seroconversion Rate of SRH Antibody Titer (cell-derived antigen)

    Seroconversion Rate is defined as the percentage of participants with a baseline SRH antibody titer of ≥ 4 mm^2 achieving a minimal 50 percent increase, or baseline HI antibody titer of < 4 mm^2 achieving an SRH antibody titer of ≥ 25 mm^2 for each of the four strains (A/H1N1 strain, A/H3N2 strain, B/Yamagata strain, B/Victoria strain).

    Measured: Day 22

  14. GMFI in SRH Antibody Titer (cell-derived antigen)

    Measured: Day 22

  15. GMT of SRH Antibody Titer (cell-derived antigen)

    Measured: Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionApr 2016 (estimated)
  4. Study completionApr 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02713061
Sponsor's protocol ID
TAK-850/CPH-004
Other IDs
U1111-1178-8045
Status last verified
Aug 2016
First submitted
15 Mar 2016
Last updated
25 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-850 in people with Influenza Prevention, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: Up to Day 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02713061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.

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