InfluenzaPhase 1/2NCT02111252

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

A Phase 1/2 study testing TAK-850 in people with Influenza, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 20 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: TAK-850
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteJapan
Study dates: Mar 2014to Apr 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Sumida-ku, Tokyo

Other trials in Japan

About this study

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

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

Read the detailed 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

Conditions: Influenza
Being tested: TAK-850
Keywords: Drug Therapy
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-850Drug
TAK-850 injection

Study groups in NCT02111252
Study group	Role	What they receive
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. Receives: Drug: TAK-850

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Day 22

Secondary outcomes (7)

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.
Measured: Day 1 (Baseline), Day 8, Day 22
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).
Measured: Day 1 and Day 22
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
Measured: Day 22
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.
Measured: Day 22
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.
Measured: Day 22
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.
Measured: Day 22
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.
Measured: Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Apr 2014

First posted11 Apr 2014 (estimated)
Study startMar 2014
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02111252
Sponsor's protocol ID: TAK-850/CPH-001
Other IDs: U1111-1153-8702
Status last verified: Jun 2015
First submitted: 11 Mar 2014
Last updated: 27 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02111252
Acronym / sponsor ID: TAK-850/CPH-001
Conditions: Influenza
Keywords: Drug Therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 11 Apr 2014 (estimated)
Results: Posted 27 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed 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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAK-850 0.5 mL	Experimental	Drug: TAK-850A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.

Who may qualify

Ages: 20 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-850TAK-850 injection	Drug	TAK-850 0.5 mL

Primary outcome

Number of Participants With Solicited Injection Site and Systemic Adverse Events
Time frame: For 22 days
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.
Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
Time frame: Day 22
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).
Seroconversion Rate of HI AntibodyTiter
Time frame: Day 22
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).
Geometric Mean Fold Increase in HI Antibody Titer
Time frame: Day 22
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.

7 secondary outcomes

Change From Baseline in Blood Pressure
Time frame: Day 1 (Baseline), Day 8, Day 22
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
Time frame: Day 1 and Day 22
Geometric Mean Titer (GMT) of HI Antibody Titer
Time frame: Day 22
GMT of Single Radial Hemolysis (SRH) Antibody Titer
Time frame: Day 22
Seroprotection Rate of SRH Antibody Titer
Time frame: Day 22
Seroconversion Rate of SRH Antibody Titer
Time frame: Day 22
Geometric Mean Fold Increase in SRH Antibody Titer
Time frame: Day 22

Results and safety

Results posted to the registry on 27 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-850 0.5 mL	55	55

Primary outcome: Number of Participants With Solicited Injection Site and Systemic Adverse Events

Time frame: For 22 days. Number. Unit: participants

Measure	TAK-850 0.5 mL n = 55
Arthralgia	1
Chills	2
Fatigue	1
Headache	3
Injection site ecchymosis (haemorrhage)	1
Injection site pain	9
Injection site tenderness (Injection site pain)	18
Malaise	9

Population analysed: The safety analysis set, comprised the volunteers who received a single dose of 0.5 mL TAK-850, was used.

Primary outcome: Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer

Time frame: Day 22. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	TAK-850 0.5 mL n = 55
A/H1N1 strain Pre-vaccination (Day 1)	34.5 (22.237 to 48.581)
A/H1N1 strain 21 Days Post-vaccination (Day 22)	81.8 (69.095 to 90.921)
A/H3N2 strain Pre-vaccination (Day 1)	63.6 (49.563 to 76.186)
A/H3N2 strain 21 Days Post-vaccination (Day 22)	87.3 (75.520 to 94.726)
B strain Pre-vaccination (Day 1)	20.0 (10.430 to 32.973)
B strain 21 Days Post-vaccination (Day 22)	76.4 (62.980 to 86.772)

Population analysed: The full analysis set was used.

Primary outcome: Seroconversion Rate of HI AntibodyTiter

Time frame: Day 22. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	TAK-850 0.5 mL n = 55
A/H1N1 strain	70.9 (57.102 to 82.370)
A/H3N2 strain	52.7 (38.804 to 66.347)
B strain	61.8 (47.726 to 74.591)

Primary outcome: Geometric Mean Fold Increase in HI Antibody Titer

Time frame: Day 22. Geometric mean (95% Confidence Interval). Unit: Fold Change

Measure	TAK-850 0.5 mL n = 55
A/H1N1 strain	14.74 (7.412)
A/H3N2 strain	6.71 (6.783)
B strain7.14	7.14 (5.123)

Population analysed: The full analysis set was used.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the injection of study drug until 22 days.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-850 0.5 mL	0 of 55 (0%)	30 of 55 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

General Manager study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAK-850 in people with Influenza, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Injection Site and Systemic Adverse Events (time frame: For 22 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02111252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.