A Phase 2 Study of Trivalent Inactivated Influenza Vaccine (TIV), TAK-850 (Cell-culture Derived) Compared to TIV (Egg-derived) in Adults

Influenza Clinical Trial

Official title:

A Phase 2 Randomized Double Blind Parallel-Group Comparative Study to Evaluate the Immunogenicity and Safety of a Single Subcutaneous Injection of Trivalent Inactivated Influenza Virus Vaccine (TIV), TAK-850 (Cell-culture Derived) to TIV (Egg-derived) in Healthy Adults Aged 20-49 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555618
• Other study ID #: TAK-850/CPH-003
• Secondary ID: U1111-1174-1290T
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2015
• Last updated: July 21, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg -derived TIV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• 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 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/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.

Exlusion 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 has been previously injected with TAK-850.

5. 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.

6. 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.

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

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

9. 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 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.

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

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

12. The participant has a functional or surgical asplenia.

13. The participant has a rash, other dermatologic conditions, or tattoos which may interfere with the evaluation of injection site reaction.

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

15. The participant has a known hypersensitivity to any component of TAK-850 or Influenza HA Vaccine.

16. The participant has a history of severe allergic reactions or anaphylaxis.

17. 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 excessive alcohol and drugs throughout the study.

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

19. 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.

20. If female, the participant is pregnant or lactating or intending to become pregnant before signing informed consent, during, or within 12 weeks after injection of study vaccine; or intending to donate ova during such time period.

21. 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.

22. 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 laboratory 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• TAK-850
TAK-850 vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate of hemagglutination inhibition (HI) antibody titer (egg-derived antigen)	Seroconversion rate as 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.	Day 22	No
Primary	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	Days 1 and 22	No
Secondary	Seroprotection rate of HI antibody titer (egg-derived antigen)	Seroprotection rate as measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.	Days 1 and 22	No
Secondary	Geometric mean fold increase in HI antibody titer (egg-derived antigen)	Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with baseline.	Day 22	No
Secondary	Seroconversion rate of single radial hemolysis (SRH) antibody titer (egg-derived antigen)	Seroconversion rate as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.	Day 22	No
Secondary	GMT of SRH antibody titer (egg-derived antigen)	GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.	Days 1 and 22	No
Secondary	Seroprotection rate of SRH antibody titer (egg-derived antigen)	Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.	Days 1 and 22	No
Secondary	Geometric mean fold increase in SRH antibody titer (egg-derived antigen)	Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with baseline.	Day 22	No
Secondary	Seroconversion rate of HI antibody titer (cell-derived antigen)	Seroconversion rate as measured by HI antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination.	Day 22	No
Secondary	GMT of HI antibody titer (cell-derived antigen)	GMT of HI antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination.	Days 1 and 22	No
Secondary	Seroprotection rate of HI antibody titer (cell-derived antigen)	Seroprotection rate as measured by HI antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination.	Seroprotection rate of HI antibody titer (cell-derived antigen)	No
Secondary	Geometric mean fold increase in HI antibody titer (cell-derived antigen)	Geometric mean fold increase in HI antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination, as compared with baseline.	Day 22	No
Secondary	Seroconversion rate of SRH antibody titer (cell-derived antigen)	Seroconversion rate as measured by SRH antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination.	Day 22	No
Secondary	GMT of SRH antibody titer (cell-derived antigen)	GMT of SRH antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination.	Days 1 and 22	No
Secondary	GMT of SRH antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination.	Seroprotection rate as measured by SRH antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination.	Days 1 and 22	No
Secondary	Geometric mean fold increase in SRH antibody titer (cell-derived antigen)	Geometric mean fold increase in SRH antibody titer (cell-derived antigen) for each of the three strains, 21 days after vaccination, as compared with baseline.	Geometric mean fold increase in SRH antibody titer (cell-derived antigen)	No
Secondary	Number of participants with solicited local and systemic adverse events (AEs)	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.	22 days	Yes
Secondary	Number of Participants Reporting One or More Treatment-emergent Adverse Events	The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.	22 days	Yes
Secondary	Percentage of participants who meet the Takeda markedly abnormal criteria for safety laboratory tests at least once post dose	The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study.	Days 1 and 22	Yes