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Influenza InfectionPhase 1/2NCT02313155

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

A Phase 1/2 study testing Subcutaneous injection of TAK-850 and Intramuscular injection of TAK-850 in people with Influenza Infection, run by Takeda.

Completed

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

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza Infection
What is being tested?
Subcutaneous injection of TAK-850 and Intramuscular injection of TAK-850
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
Dec 2014to Jan 2015
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

  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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

Read the 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.

Being tested
Subcutaneous injection of TAK-850, Intramuscular injection of TAK-850
Keywords
Prevention

What participants receive

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

  • Subcutaneous injection of TAK-850Drug

    TAK-850 0.5 mL, Subcutaneous injection

  • Intramuscular injection of TAK-850Drug

    TAK-850 0.5 mL, Intramuscular injection

Study groups in NCT02313155
Study groupRoleWhat they receive
TAK-850 0.5 mL (subcutaneous)ExperimentalSingle subcutaneous injection of TAK-850
Receives: Drug: Subcutaneous injection of TAK-850
TAK-850 0.5 mL (Intramuscular)ExperimentalSingle intramuscular injection of TAK-850
Receives: Drug: Intramuscular injection of TAK-850

What is being measured

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

  1. 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.

    Measured: Up to 21 days (Day 22) after vaccination

  2. 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.

    Measured: Up to 21 days (Day 22) after vaccination

  3. 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).

    Measured: Day 22 (21 days after vaccination)

  4. 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).

    Measured: Day 22 (21 days after vaccination)

  5. 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.

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

Secondary outcomes (17)

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

    Laboratory values included hematology, biochemistry and urinalysis tests.

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

  2. Change From Baseline in Blood Pressure

    Change from baseline in systolic and diastolic blood pressure was reported

    Measured: Baseline, Day 22

  3. Change From Baseline in Pulse

    Change from baseline in pulse was reported.

    Measured: Baseline, Day 22

  4. Change From Baseline in Body Temperature

    Change from baseline in body temperature (oral) was reported.

    Measured: Baseline, Day 22

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

    GMT in HI antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.

    Measured: Day 22 (21 days after vaccination)

  6. Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2

    Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) was defined as percentage of participants with an SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

    Measured: Day 22 (21 days after vaccination)

  7. Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)

    Seroconversion rate as measured by the SRH antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

    Measured: Day 22 (21 days after vaccination)

  8. GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination

    GMFI in SRH antibody titer (egg-derived antigen) as compared to baseline 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.

    Measured: Pre-vaccination, 21 Days after vaccination (Day 22)

  9. GMT in SRH Antibody Titer (Egg-derived Antigen)

    GMT in SRH antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.

    Measured: Day 22 (21 days after vaccination)

  10. Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40

    Seroprotection rate as measured by HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with an HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

    Measured: Day 22 (21 days after vaccination)

  11. Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)

    Seroconversion rate as measured by the HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] 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 HI <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

    Measured: Day 22 (21 days after vaccination)

  12. GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination

    GMFI in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] 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.

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

  13. GMT in HI Antibody Titer (Cell Derived Antigen)

    GMT in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.

    Measured: Day 22 (21 days after vaccination)

  14. Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2

    Seroprotection rate as measured by SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with a SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

    Measured: Day 22 (21 days after vaccination)

  15. Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)

    Seroconversion rate as measured by the SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).

    Measured: Day 22 (21 days after vaccination)

  16. GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination

    GMFI in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] 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.

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

  17. GMT in SRH Antibody Titer (Cell Derived Antigen)

    GMT in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.

    Measured: Day 22 (21 days after vaccination)

Timeline

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

  1. First posted9 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313155
Sponsor's protocol ID
TAK-850/CPH-002
Other IDs
U1111-1164-1969, JapicCTI-142724
Status last verified
Jan 2016
First submitted
5 Dec 2014
Last updated
17 Feb 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Subcutaneous injection of TAK-850 and Intramuscular injection of TAK-850 in people with Influenza Infection, run by Takeda.

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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

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 17 Feb 2016). 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 Reporting Solicited Local and Systemic Adverse Events (AEs) (time frame: Up to 21 days (Day 22) after vaccination). The study lists 5 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 NCT02313155.

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 17 Feb 2016.

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