Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza Infection

Keywords

Prevention

Outcome Measures

Primary Outcomes (5)

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.
Up to 21 days (Day 22) after vaccination
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.
Up to 21 days (Day 22) after vaccination
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).
Day 22 (21 days after vaccination)
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)

Secondary Outcomes (17)

Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
Baseline,up to 21 Days after drug administration (Day 22)
Change From Baseline in Blood Pressure
Baseline, Day 22
Change From Baseline in Pulse
Baseline, Day 22
Change From Baseline in Body Temperature
Baseline, Day 22
Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)
Day 22 (21 days after vaccination)
+12 more secondary outcomes

Study Arms (2)

TAK-850 0.5 mL (subcutaneous)

EXPERIMENTAL

Single subcutaneous injection of TAK-850

Drug: Subcutaneous injection of TAK-850

TAK-850 0.5 mL (Intramuscular)

EXPERIMENTAL

Single intramuscular injection of TAK-850

Drug: Intramuscular injection of TAK-850

Interventions

Subcutaneous injection of TAK-850Drug

TAK-850 0.5 mL, Subcutaneous injection

TAK-850 0.5 mL (subcutaneous)

Intramuscular injection of TAK-850Drug

TAK-850 0.5 mL, Intramuscular injection

TAK-850 0.5 mL (Intramuscular)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 49 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
\. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.

Sponsors & Collaborators

Takeda
Industrylead

Results Point of Contact

Title: Medical Director
Organization: Takeda

Study Officials

Senior VP Clinical Science
Takeda
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

110 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 9, 2014

Study Start

December 2014

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

\. The participant has received any investigational compound within 4 months prior to the injection of study vaccine.
\. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the injection of study vaccine.
\. The participant has a history of influenza infection within 6 months prior to the injection of study vaccine.
\. 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.
\. 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.
\. The participant has an oral temperature ≥37.5 °C prior to the injection of study vaccine on Day 1.
\. The participant has any medically diagnosed or suspected immune deficient condition.
\. 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.
\. The participant has received antipyretics within 4 hours prior to the injection of study vaccine.
\. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis) or convulsions.
\. 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.
\. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
\. 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.
\. The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the injection of study vaccine.
\. 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.
+4 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (17)

Study Arms (2)

TAK-850 0.5 mL (subcutaneous)

TAK-850 0.5 mL (Intramuscular)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (17)

Study Arms (2)

TAK-850 0.5 mL (subcutaneous)

TAK-850 0.5 mL (Intramuscular)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record