Clinical trial NCT02313155: Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults
Official title: A Randomized Double Blind Parallel-Group Comparative Phase 1/2 Study to Evaluate the Safety and Immunogenicity of a Single Subcutaneous Injection of TAK-850 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza Infection
Keywords: Prevention
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: The drug being tested in this study is called TAK-850. This drug is being tested to evaluate the safety and immunogenicity of a single subcutaneous injection as compared to a single, intramuscular injection.

A total of 110 healthy participants (55 per group) will take part in this study.

Each participant will be randomly (like flipping a coin) assigned to receive one of the following :

* A single injection of TAK-850, subcutaneously , or
* A single injection of TAK-850, intramuscularly.

Participants will make up to 3 visits to the study site. Total duration of this study is 22 days.

Eligibility criteria: Inclusion Criteria:

* In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.

  2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.

  3. 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.

  5. The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m\^2, inclusive, at the time of eligibility evaluation.

  6. 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.

Exclusion Criteria:

* 1. The participant has received any investigational compound within 4 months prior to the injection of study vaccine.

  2. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the injection of study vaccine.

  3. The participant has a history of influenza infection within 6 months prior to the 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.

  5. 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.

  6. The participant has an oral temperature ≥37.5 °C prior to the injection of study vaccine on Day 1.

  7. The participant has any medically diagnosed or suspected immune deficient condition.

  8. 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.

  9. The participant has received antipyretics within 4 hours prior to the injection of study vaccine.

  10. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis) or convulsions.

  11. 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.

  13. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).

  14. 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.

  17. The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the injection of study vaccine.

  18. 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.

  19. 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.

  20. 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 injection of study vaccine.

  21. The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the 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.

  22. In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.

Primary outcomes:
measure: Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
timeFrame: Up to 21 days (Day 22) after vaccination
measure: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to 21 days (Day 22) after vaccination
measure: Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.
timeFrame: Day 22 (21 days after vaccination)
measure: Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
measure: Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
timeFrame: Pre-vaccination, 21 Days After vaccination (Day 22)
Secondary outcomes:
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
timeFrame: Baseline,up to 21 Days after drug administration (Day 22)
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline, Day 22
measure: Change From Baseline in Pulse
timeFrame: Baseline, Day 22
measure: Change From Baseline in Body Temperature
timeFrame: Baseline, Day 22
measure: Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
measure: Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2
timeFrame: Day 22 (21 days after vaccination)
measure: Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
measure: GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
timeFrame: Pre-vaccination, 21 Days after vaccination (Day 22)
measure: GMT in SRH Antibody Titer (Egg-derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
measure: Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
timeFrame: Day 22 (21 days after vaccination)
measure: Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
measure: GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
timeFrame: Pre-vaccination, 21 Days After vaccination (Day 22)
measure: GMT in HI Antibody Titer (Cell Derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
measure: Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
timeFrame: Day 22 (21 days after vaccination)
measure: Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
measure: GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
timeFrame: Pre-vaccination, 21 Days After vaccination (Day 22)
measure: GMT in SRH Antibody Titer (Cell Derived Antigen)
timeFrame: Day 22 (21 days after vaccination)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Senior VP Clinical Science
role: STUDY_DIRECTOR
References: