Trials Sponsors Conditions Drugs Pricing

Conditions

Pandemic Influenza Prevention

Outcome Measures

Primary Outcomes (3)

Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination
Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm\^2.
Day 43 (21 days after the second vaccination)
Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination
Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroconversion rate as SRH antibody titer is defined as the percentage of participants with a 50% or more increase in SRH antibody titer from baseline for those who have a baseline value \>4 mm\^2 or SRH antibody titer ≥25 mm\^2 for those who have a baseline value ≤4 mm\^2.
Day 43 (21 days after the second vaccination)
Geometric Mean Fold Increase (GMFI) in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the Second Vaccination
GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination.
Day 43 (21 days after the second vaccination)

Secondary Outcomes (11)

Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination
Day 22 (21 days after the first vaccination)
Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination
Day 22 (21 days after the first vaccination)
GMFI in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the First Vaccination
Day 22 (21 days after the first vaccination)
Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 Days After Each Vaccination
Day 22, and Day 43 (21 days after the first and the second vaccination)
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
Up to Day 43
+6 more secondary outcomes

Study Arms (1)

BLB-750 Qinghai RG strain

EXPERIMENTAL

Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 µg per strain) will be injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.

Biological: BLB-750 Vaccine (Qinghai RG strain)

Interventions

BLB-750 Vaccine (Qinghai RG strain)Biological

BLB-750 Injection

Also known as: Cell-Culture Influenza Vaccine H5N1 "Takeda"

BLB-750 Qinghai RG strain

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, 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

Study Sites (1)

Sekino Rinsho Yakuri Clinic

Toshima-ku, Tokyo, Japan

Results Point of Contact

Title: Medical Director
Organization: Takeda

Study Officials

Study Director
Takeda
STUDY DIRECTOR

Publication Agreements

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

Enrollment

55 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 12, 2017

Study Start

January 12, 2018

Actual (reported)

You may not qualify if:

The participant has received vaccination with any other investigational products within 4 months prior to vaccination with the study drug.
The participant has a history of vaccination with an H5N1 influenza vaccine.
The participant has a history of infection with H5N1 virus.
The participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
The participant has poorly controlled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine, or other disorders, which may impact their ability to participate as participants or may potentially confound the study results.
The participant has a body temperature (oral) ≥37.5°C prior to vaccination with the study drug on Day 1.
The participant has any medically diagnosed or suspected immune-deficiency condition.
The participant has an immunocompromising 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 vaccination with the study drug.
Such treatments include, but are 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.
The participant has received antipyretics within 4 hours prior to vaccination with the study drug.
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 anatomic asplenia.
The participant has a rash, other dermatologic conditions or tattoos that may interfere with the evaluation of local reaction.
The participant has a past or present history of infection with the Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
+13 more criteria

A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (11)

Study Arms (1)

BLB-750 Qinghai RG strain

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (11)

Study Arms (1)

BLB-750 Qinghai RG strain

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations