A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects

NCT02111252 | Completed Phase 1 Results

• 2 other identifiers: TAK-850/CPH-001U1111-1153-8702
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants

Conditions

Influenza

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Solicited Injection Site and Systemic Adverse Events

  Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.

  For 22 days

• Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer

  Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).

  Day 22

• Seroconversion Rate of HI AntibodyTiter

  Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage 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 three strains (A/H1N1 strain, A/H3N2 strain, B strain).

  Day 22

• Geometric Mean Fold Increase in HI Antibody Titer

  Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.

  Day 22

Secondary Outcomes (7)

• Change From Baseline in Blood Pressure

  Day 1 (Baseline), Day 8, Day 22

• Change From Baseline in Safety Electrocardiogram (ECG) Parameters

  Day 1 and Day 22

• Geometric Mean Titer (GMT) of HI Antibody Titer

  Day 22

• GMT of Single Radial Hemolysis (SRH) Antibody Titer

  Day 22

• Seroprotection Rate of SRH Antibody Titer

  Day 22

Study Arms (1)

TAK-850 0.5 mL

EXPERIMENTAL

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

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. 4. 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/m2, 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 4. 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. 12. 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. 15. The participant has a history of severe allergic reactions or anaphylaxis. 16. 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Sumida-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

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

trialdisclosures@takeda.com

800-778-2860

Study Officials

• General Manager

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-06

Locations

JP (1)