Pandemic Influenza Prevention
Conditions
Brief summary
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.
Interventions
BIOLOGICALBLB-750 Vaccine (Qinghai RG strain)
BLB-750 Injection
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
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 man or woman. 4. The participant is aged 20 to 49 years, inclusive, at the time of informed consent. 5. 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.
Exclusion criteria
1. The participant has received vaccination with any other investigational products within 4 months prior to vaccination with the study drug. 2. The participant has a history of vaccination with an H5N1 influenza vaccine. 3. The participant has a history of infection with H5N1 virus. 4. The participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers). 5. 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. 6. 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. 7. The participant has a body temperature (oral) ≥37.5°C prior to vaccination with the study drug on Day 1. 8. The participant has any medically diagnosed or suspected immune-deficiency condition. 9. 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. 10. The participant has received antipyretics within 4 hours prior to vaccination with the study drug. 11. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis), or convulsions. 12. The participant has a functional or anatomic asplenia. 13. The participant has a rash, other dermatologic conditions or tattoos that may interfere with the evaluation of local reaction. 14. 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). 15. The participant has a known hypersensitivity to any component of BLB-750. 16. The participant has a history of severe allergic reactions or anaphylaxis. 17. 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. 18. The participant has received any blood product (e.g., blood transfusion or immunoglobulin) within 90 days prior to vaccination with the study drug. 19. 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. 20. 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. 21. 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. 22. 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. 23. The participant has donated blood components within 2 weeks (14 days) prior to the first vaccination with the study drug. 24. In the opinion of the investigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason. 25. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | GMT was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first and second vaccination. |
| Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | Up to Day 43 | 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. |
| Number of Participants With Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary | Up to Day 43 | Local reactions and systemic events were recorded using a diary. |
| Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination | 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 | — |
| 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) | 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. |
| Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination | 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 | 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 | 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 | — |
| Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination | 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 | — |
| 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) | 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. |
| 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) | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at one investigative site in Japan, from 12 January 2018 to 28 February 2018.
Pre-assignment details
Healthy volunteer were enrolled and vaccinated the study drug, BLB-750 at a 3-week interval (Day 1 and Day 22) in a treatment period of 43 days through intramuscular route.
Participants by arm
| Arm | Count |
|---|---|
| Overall (BLB-750 Vaccine) 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) were 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. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Sample Size Sufficient | 4 |
| Overall Study | Screen Failure | 1 |
Baseline characteristics
| Characteristic | Overall (BLB-750 Vaccine) | — |
|---|---|---|
| Age, Continuous | 28.3 Years STANDARD_DEVIATION 4.52 | — |
| Body Mass Index (BMI) | 21.29 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.657 | — |
| Height | 165.5 Centimeter (cm) STANDARD_DEVIATION 9.06 | — |
| Number of Participants who Had No Infection of Influenza within 1 Year prior to Study Start | 55 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 55 Participants | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 27 Participants | — |
| Single Radial Hemolysis (SRH) Antibody Titer | 4.0 mm^2 STANDARD_DEVIATION 0 | — |
| Weight | 58.43 Kilogram (kg) STANDARD_DEVIATION 7.567 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 25 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
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.
Time frame: Day 43 (21 days after the second vaccination)
Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Overall (BLB-750 Vaccine) | Geometric Mean Fold Increase (GMFI) in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the Second Vaccination | 3.5636 Fold change |
Primary
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.
Time frame: Day 43 (21 days after the second vaccination)
Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall (BLB-750 Vaccine) | Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination | 32.7 Percentage of participants |
Primary
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.
Time frame: Day 43 (21 days after the second vaccination)
Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall (BLB-750 Vaccine) | Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination | 32.7 Percentage of participants |
Secondary
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
Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination | At 30 Minutes after the 1st Vaccination | -1.0 mmHg | Standard Deviation 6.59 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination | Day 22 after the 1st Vaccination | 0.4 mmHg | Standard Deviation 11.53 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination | At 30 Minutes after the 2nd Vaccination | 0.0 mmHg | Standard Deviation 9.81 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination | Day 22 after the 2nd vaccination | -0.7 mmHg | Standard Deviation 11.89 |
Secondary
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
Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination | At 30 Minutes after the 1st Vaccination | -4.7 Beats per minutes | Standard Deviation 6.54 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination | Day 22 after the 1st Vaccination | 5.5 Beats per minutes | Standard Deviation 9.96 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination | At 30 Minutes after the 2nd Vaccination | -8.6 Beats per minutes | Standard Deviation 7.2 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination | Day 22 after the 2nd vaccination | -0.4 Beats per minutes | Standard Deviation 8.49 |
Secondary
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
Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination | At 30 Minutes after the 1st Vaccination | -0.6 Breaths per minutes | Standard Deviation 1.38 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination | At 30 Minutes after the 2nd Vaccination | -0.7 Breaths per minutes | Standard Deviation 1.72 |
Secondary
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
Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination | At 30 Minutes after the 1st Vaccination | -2.2 mmHg | Standard Deviation 8.57 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination | Day 22 after the 1st Vaccination | 3.2 mmHg | Standard Deviation 10.73 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination | At 30 Minutes after the 2nd Vaccination | -3.3 mmHg | Standard Deviation 11.19 |
| Overall (BLB-750 Vaccine) | Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination | Day 22 after the 2nd vaccination | -4.2 mmHg | Standard Deviation 11.06 |
Secondary
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.
Time frame: Day 22, and Day 43 (21 days after the first and the second vaccination)
Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Overall (BLB-750 Vaccine) | Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 Days After Each Vaccination | Day 22 | 9.3277 mm^2 |
| Overall (BLB-750 Vaccine) | Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 Days After Each Vaccination | Day 43 | 14.2543 mm^2 |
Secondary
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.
Time frame: Day 22 (21 days after the first vaccination)
Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Overall (BLB-750 Vaccine) | GMFI in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the First Vaccination | 2.3319 Fold change |
Secondary
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
Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 1 after the 1st Vaccination | 36.70 degree Celsius | Standard Deviation 0.356 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 2 after the 1st Vaccination | 36.65 degree Celsius | Standard Deviation 0.324 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 5 after the 2nd Vaccination | 36.60 degree Celsius | Standard Deviation 0.403 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 3 after the 1st Vaccination | 36.73 degree Celsius | Standard Deviation 0.329 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 4 after the 1st Vaccination | 36.64 degree Celsius | Standard Deviation 0.397 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 5 after the 1st Vaccination | 36.71 degree Celsius | Standard Deviation 0.293 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 6 after the 1st Vaccination | 36.65 degree Celsius | Standard Deviation 0.351 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 7 after the 1st Vaccination | 36.69 degree Celsius | Standard Deviation 0.288 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 1 after the 2nd Vaccination | 36.70 degree Celsius | Standard Deviation 0.363 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 2 after the 2nd Vaccination | 36.65 degree Celsius | Standard Deviation 0.322 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 3 after the 2nd Vaccination | 36.65 degree Celsius | Standard Deviation 0.377 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 4 after the 2nd Vaccination | 36.64 degree Celsius | Standard Deviation 0.374 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 6 after the 2nd Vaccination | 36.72 degree Celsius | Standard Deviation 0.361 |
| Overall (BLB-750 Vaccine) | Mean Body Temperature at Specific Time Points After Vaccination | Day 7 after the 2nd Vaccination | 36.67 degree Celsius | Standard Deviation 0.304 |
Secondary
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.
Time frame: Up to Day 43
Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall (BLB-750 Vaccine) | Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | 25 Participants |
Secondary
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.
Time frame: Up to Day 43
Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall (BLB-750 Vaccine) | Number of Participants With Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary | 24 Participants |
Secondary
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.
Time frame: Day 22 (21 days after the first vaccination)
Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall (BLB-750 Vaccine) | Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination | 10.9 Percentage of participants |
Secondary
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.
Time frame: Day 22 (21 days after the first vaccination)
Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall (BLB-750 Vaccine) | Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination | 10.9 Percentage of participants |