Pandemic Influenza PreventionPhase 4NCT03370289
A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects
A Phase 4 study testing BLB-750 Vaccine (Qinghai RG strain) in people with Pandemic Influenza Prevention, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular vaccinations with BLB-750 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
- Pandemic Influenza Prevention
- What is being tested?
- BLB-750 Vaccine (Qinghai RG strain)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteJapan
- Study dates
- 12 Jan 2018to 28 Feb 2018
- Phase
- Phase 4
- 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, 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.
- The participant is a healthy Japanese adult man or woman.
- The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
- A female participant 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
- 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.
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- 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).
- The participant has a known hypersensitivity to any component of BLB-750.
- The participant has a history of severe allergic reactions or anaphylaxis.
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol dependence within 1 year prior to vaccination with the study drug or is unwilling to agree to abstain from excessive alcohol and drugs throughout the study.
- The participant has received any blood product (e.g., blood transfusion or immunoglobulin) within 90 days prior to vaccination with the study drug.
- The participant has received any live vaccine within 4 weeks (28 days) prior to vaccination with the study drug or any inactivated vaccine within 2 weeks (14 days) prior to vaccination with the study drug.
- The participant is a pregnant or lactating woman or wishes to become pregnant before signing informed consent, during, or within 12 weeks after the last vaccination with the study drug or intends to donate ova during such time period.
- For males: The participant has donated whole blood ≥200 mL within 4 weeks (28 days) or ≥400 mL within 12 weeks (84 days) prior to the first vaccination with the study drug.
- For females: The participant has donated whole blood ≥200 mL within 4 weeks (28 days) or ≥400 mL within 16 weeks (112 days) prior to the first vaccination with the study drug.
- For males: The participant has donated whole blood ≥800 mL in total within 52 weeks (364 days) prior to the first vaccination with the study drug.
- For females: The participant has donated whole blood ≥400 mL in total within 52 weeks (364 days) prior to the first vaccination with the study drug.
- The participant has donated blood components within 2 weeks (14 days) prior to the first vaccination with the study drug.
- In the opinion of the investigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.
- The participant has presence of thrombocytopenia or coagulopathy, or has received anticoagulant therapy within 30 days prior to the first vaccination with the study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Phase 4 Study to Evaluate the Immunogenicity and Safety of Intramuscular Injections of BLB-750 in Healthy Adult Subjects
The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular vaccinations with BLB-750 in healthy Japanese adults.
Read the detailed description
The drug being tested in this study is called BLB-750 that is a vaccine for pandemic influenza infection. This study will evaluate immunogenicity and safety of two intramuscular vaccinations with BLB-750 at 3-week intervals in healthy Japanese adults. The study will enroll 55 participants. BLB-750 will be administered in opened manner:
- Two intramuscular vaccinations of BLB-750 at 3-week intervals, 0.5 mL
This trial will be conducted in Japan. The overall time to participate in this study will be 43 days, starting on the day of first vaccination. Participants will make multiple visits to the clinic, including 21 days after the first vaccination and 21 days after the second vaccination.
- Conditions
- Pandemic Influenza Prevention
- Being tested
- BLB-750 Vaccine (Qinghai RG strain)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLB-750 Vaccine (Qinghai RG strain)Biological
Also called Cell-Culture Influenza Vaccine H5N1 "Takeda"
BLB-750 Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: BLB-750 Vaccine (Qinghai RG strain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm^2.
Measured: 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
Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first 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.
Measured: 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
GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination.
Measured: 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
GMT was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first and second vaccination.
Measured: 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)
An Adverse Event (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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Up to Day 43
Number of Participants With Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary
Local reactions and systemic events were recorded using a diary.
Measured: Up to Day 43
Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination
Measured: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination
Measured: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination
Measured: At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination
Measured: Baseline, At 30 minutes after the first vaccination, and at 30 minutes after the second vaccination
Mean Body Temperature at Specific Time Points After Vaccination
Measured: Baseline, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the first vaccination, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start12 Jan 2018
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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 Pandemic Influenza PreventionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370289
- Sponsor's protocol ID
- BLB-750/CCT-901
- Other IDs
- U1111-1198-2695, JapicCTI-173797
- Status last verified
- Jun 2019
- First submitted
- 7 Dec 2017
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 4 Study to Evaluate the Immunogenicity and Safety of Intramuscular Injections of BLB-750 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03370289
- Acronym / sponsor ID
- BLB-750/CCT-901
- Conditions
- Pandemic Influenza Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular vaccinations with BLB-750 in healthy Japanese adults.
Detailed description
The drug being tested in this study is called BLB-750 that is a vaccine for pandemic influenza infection. This study will evaluate immunogenicity and safety of two intramuscular vaccinations with BLB-750 at 3-week intervals in healthy Japanese adults. The study will enroll 55 participants. BLB-750 will be administered in opened manner:
- Two intramuscular vaccinations of BLB-750 at 3-week intervals, 0.5 mL
This trial will be conducted in Japan. The overall time to participate in this study will be 43 days, starting on the day of first vaccination. Participants will make multiple visits to the clinic, including 21 days after the first vaccination and 21 days after the second vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLB-750 Qinghai RG strain | Experimental | Biological: BLB-750 Vaccine (Qinghai RG strain)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. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- The participant is a healthy Japanese adult man or woman.
- The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
- A female participant 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 (28 listed)
- 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.
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 |
|---|---|---|
| BLB-750 Vaccine (Qinghai RG strain)Also: Cell-Culture Influenza Vaccine H5N1 "Takeda"BLB-750 Injection | Biological | BLB-750 Qinghai RG strain |
Primary outcome
Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination
Time frame: Day 43 (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.
Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination
Time frame: Day 43 (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.
Geometric Mean Fold Increase (GMFI) in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the Second Vaccination
Time frame: Day 43 (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.
11 secondary outcomes
Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to Day 43
Number of Participants With Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary
Time frame: Up to Day 43
Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination
Time frame: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination
Time frame: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination
Time frame: At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination
Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination
Time frame: Baseline, At 30 minutes after the first vaccination, and at 30 minutes after the second vaccination
Mean Body Temperature at Specific Time Points After Vaccination
Time frame: Baseline, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the first vaccination, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the second vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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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.
Study Director 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 4 study testing BLB-750 Vaccine (Qinghai RG strain) in people with Pandemic Influenza Prevention, 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 28 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 29 Jul 2019. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 29 Jul 2019). 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?
Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination (time frame: Day 43 (21 days after the second vaccination)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2019.