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

NCT02555618 | Completed Phase 2 Results

• 3 other identifiers: TAK-850/CPH-003U1111-1174-1290JapicCTI-153019
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Influenza Infection

Keywords

Vaccine

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Days 1 and 22

Secondary Outcomes (17)

• Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)

  Days 1 and 22

• Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)

  Baseline and Day 22

• Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)

  Baseline and Day 22

• GMT of SRH Antibody Titer (Egg-Derived Antigen)

  Days 1 and 22

• Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)

  Days 1 and 22

Study Arms (2)

TAK-850

EXPERIMENTAL

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

Influenza HA Vaccine

ACTIVE COMPARATOR

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

TAK-850 BIOLOGICAL

TAK-850 subcutaneous injection

TAK-850

Influenza HA vaccine BIOLOGICAL

Influenza HA vaccine subcutaneous injection

Influenza HA Vaccine

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 or subinvestigator, 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 the eligibility evaluation.
• 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.

You may not qualify if:

• The participant has received any investigational compound within 4 months prior to injection of study vaccine.
• The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to injection of study vaccine.
• The participant has a history of influenza infection within 6 months prior to injection of study vaccine.
• The participant has been vaccinated with TAK-850 before.
• 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 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 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.
• The participant has received antipyretics within 4 hours prior to the 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.
• 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 known hypersensitivity to any component of TAK-850 or Influenza HA Vaccine.

Sponsors & Collaborators

• Takeda: lead

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-11