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

Influenza Clinical Trial

Official title:

An Open-label Phase 1/2 Study to Evaluate the Safety and Immunogenicity of a Single Intramuscular Injection of TAK-850 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111252
• Other study ID #: TAK-850/CPH-001
• Secondary ID: U1111-1153-8702
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 11, 2014
• Last updated: June 30, 2015
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Description:

The primary objective of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of TAK-850 for 22 days in healthy Japanese adults

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 49 Years

Eligibility

Inclusion Criteria:

• 1. In the opinion of the investigator, 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/m2, 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 initial injection of study vaccine.

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

3. 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.

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 initial 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 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.

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

21. The participant has abnormal (clinically significant) electrocardiogram (ECG) at the assessment prior to the initial injection of study vaccine.

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

23. 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza

Intervention

Drug:
• TAK-850
TAK-850 injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change From Baseline in Blood Pressure	For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.	Day 1 (Baseline), Day 8, Day 22	Yes
Secondary	Change From Baseline in Safety Electrocardiogram (ECG) Parameters	The ECG data will be analyzed into 3 categories, `normal`, `abnormal but not clinically significant` and `abnormal clinically significant`. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).	Day 1 and Day 22	Yes
Secondary	Geometric Mean Titer (GMT) of HI Antibody Titer	Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination	Day 22	No
Secondary	GMT of Single Radial Hemolysis (SRH) Antibody Titer	GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.	Day 22	No
Secondary	Seroprotection Rate of SRH Antibody Titer	Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.	Day 22	No
Secondary	Seroconversion Rate of SRH Antibody Titer	Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.	Day 22	No
Secondary	Geometric Mean Fold Increase in SRH Antibody Titer	Geometric mean fold increase in SRH 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	No