Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults

NCT02313155 | Completed Phase 1 Results

• 3 other identifiers: TAK-850/CPH-002U1111-1164-1969JapicCTI-142724
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in healthy Japanese adults

Conditions

Influenza Infection

Keywords

Prevention

Outcome Measures

Primary Outcomes (5)

• Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)

  Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.

  Up to 21 days (Day 22) after vaccination

• Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

  An 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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

  Up to 21 days (Day 22) after vaccination

• Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.

  Seroprotection rate as measured by HI antibody titer (egg-derived antigen) was defined as percentage of participants with the HI antibody titer of \>=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

  Day 22 (21 days after vaccination)

• Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)

  Seroconversion rate as measured by the HI antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline \>=10) or achieving an HI antibody titer of \>=40 (baseline \<10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

  Day 22 (21 days after vaccination)

• Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination

  GMFI in HI antibody titer (egg-derived antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.

  Pre-vaccination, 21 Days After vaccination (Day 22)

Secondary Outcomes (17)

• Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values

  Baseline,up to 21 Days after drug administration (Day 22)

• Change From Baseline in Blood Pressure

  Baseline, Day 22

• Change From Baseline in Pulse

  Baseline, Day 22

• Change From Baseline in Body Temperature

  Baseline, Day 22

• Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)

  Day 22 (21 days after vaccination)

Study Arms (2)

TAK-850 0.5 mL (subcutaneous)

EXPERIMENTAL

Single subcutaneous injection of TAK-850

Drug: Subcutaneous injection of TAK-850

TAK-850 0.5 mL (Intramuscular)

EXPERIMENTAL

Single intramuscular injection of TAK-850

Drug: Intramuscular injection of TAK-850

Interventions

Subcutaneous injection of TAK-850 DRUG

TAK-850 0.5 mL, Subcutaneous injection

TAK-850 0.5 mL (subcutaneous)

Intramuscular injection of TAK-850 DRUG

TAK-850 0.5 mL, Intramuscular injection

TAK-850 0.5 mL (Intramuscular)

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. 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/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 injection of study vaccine.
• \. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the injection of study vaccine.
• \. The participant has a history of influenza infection within 6 months prior to the injection of study vaccine.
• \. 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 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 injection of study vaccine. Such treatments include, but is not limited to, systemic or high dose inhaled corticosteroids (\>800 mcg/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 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 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 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 injection of study vaccine.

Sponsors & Collaborators

• Takeda: lead

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Senior VP Clinical Science

  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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 17, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-01