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

NCT02713061 | Withdrawn Phase 2

• 2 other identifiers: TAK-850/CPH-004U1111-1178-8045
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza Prevention

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to Day 22

• 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).

  Day 22

• 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).

  Day 22

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

  Day 22

Secondary Outcomes (15)

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

  Day 22

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

  Day 22

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

  Day 22

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

  Day 22

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

  Day 22

Study Arms (1)

TAK-850 0.5 mL

EXPERIMENTAL

TAK-850 0.5 mL (15 µg of hemagglutinin \[HA\] antigen per strain), subcutaneous injection, once on Day 1.

Drug: TAK-850

Interventions

TAK-850 DRUG

TAK-850 injection

TAK-850 0.5 mL

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Toshima-ku, Tokyo, Japan

Location

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

JP (1)