Immunization; Infection
Conditions
Keywords
Haemophilus influenza type b, Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine, Hib, DPT-IPV
Brief summary
The purpose of this study is to: * (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. * (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.
Detailed description
\<Cohort 1\> * Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. * Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. \<Cohort 2\> * Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. * Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
Interventions
BIOLOGICALDPT-IPV-Hib-Low（Combined Vaccine）
BIOLOGICALHib vaccine
BIOLOGICALDPT-IPV
BIOLOGICALDPT-IPV-Hib-High（Combined Vaccine）
Sponsors
The Research Foundation for Microbial Diseases of Osaka University
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 43 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions. * Written informed consent is obtained from a legal guardian (parent)
Exclusion criteria
* With past diagnosis of immunodeficiency or currently under immunosuppressive treatment * Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency * Possibility of anaphylaxis due to food or pharmaceuticals * With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis * With experience of Hib, diphteria, pertussis, tetanus or polio vaccination. * Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination * Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation * Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) * Participated in other studies within 12 weeks before obtaining consent * With the gestational age \<37 weeks or weighed less than 2500 grams at birth. * Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | 4 weeks after the primary immunization (Visit 4) | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1, 2 and 3, antibody titers (fold) \>=8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Titer of Anti-PRP Antibody | 4 weeks after the primary immunization (Visit 4) | — |
| Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 4 weeks after the booster dose (Visit 6) | — |
| Geometric Mean Antibody Titer Against Diphtheria Toxin | 4 weeks after the primary immunization (Visit 4) | — |
| Geometric Mean Antibody Titer Against Pertussis （PT） | 4 weeks after the primary immunization (Visit 4) | — |
| Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 4 weeks after the primary immunization (Visit 4) | — |
| Geometric Mean Antibody Titer Against Tetanus Toxin | 4 weeks after the primary immunization (Visit 4) | — |
| Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Baseline and 4 weeks after the primary immunization (Visit 4) | — |
| Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | 4 weeks after the booster dose (Visit 6) | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8 |
| Geometric Mean Antibody Titer Against Pertussis （FHA） | 4 weeks after the primary immunization (Visit 4) | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BK1310-High (Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. | 15 |
| BK1310-Low (Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. | 15 |
| BK1310 (Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. | 170 |
| ActHIB® and Tetrabik (Control) (Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. | 165 |
| Total | 365 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Cohort 2 | Physician Decision | 0 | 0 | 1 | 0 |
| Cohort 2 | Withdrawal by parent/guardian | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | BK1310-High | BK1310-Low | BK1310 | ActHIB® and Tetrabik (Control) | Total |
|---|---|---|---|---|---|
| Age, Customized >=2 and <3 months | 7 Participants | 6 Participants | 154 Participants | 145 Participants | 312 Participants |
| Age, Customized >=3 months | 8 Participants | 9 Participants | 16 Participants | 20 Participants | 53 Participants |
| Race/Ethnicity, Customized Asian (Japanese) | 15 Participants | 15 Participants | 170 Participants | 165 Participants | 365 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 86 Participants | 79 Participants | 181 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 84 Participants | 86 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 171 | 0 / 169 |
| other Total, other adverse events | 15 / 15 | 15 / 15 | 162 / 171 | 163 / 169 |
| serious Total, serious adverse events | 1 / 15 | 0 / 15 | 8 / 171 | 5 / 169 |
Outcome results
Primary
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1, 2 and 3, antibody titers (fold) \>=8
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (diphtheria: n=2, PT: n=1, FHA: n=1, tetanus: n=1, polio serotype1: n=5, polio serotype2: n=4, polio serotype3: n=4）
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against anti-PRP with 1 μg/mL or higher | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against diphtheria toxin | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis (FHA) | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against diphtheria toxin | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis (FHA) | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against anti-PRP with 1 μg/mL or higher | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis （PT） | 99.4 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis (FHA) | 97.6 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against anti-PRP with 1 μg/mL or higher | 100.0 percentage of participants |
| BK1310 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against diphtheria toxin | 97.6 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against pertussis (FHA) | 99.4 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against diphtheria toxin | 98.8 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against anti-PRP with 1 μg/mL or higher | 93.3 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
Secondary
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BK1310-High | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （FHA） | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| BK1310-High | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against diphtheria toxin | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 3 | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against diphtheria toxin | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （PT） | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against pertussis （FHA） | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against tetanus toxin | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310-Low | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate against polio virus serotype 2 | 100.0 percentage of participants |
Secondary
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310-High | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| BK1310-Low | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| BK1310 | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| ActHIB® and Tetrabik (Control) | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
Secondary
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310-High | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| BK1310-Low | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
Secondary
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310-High | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| BK1310-Low | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
Secondary
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 4597.60 fold change |
| BK1310-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 7822.06 fold change |
| BK1310-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 4815.04 fold change |
| BK1310-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 1910.85 fold change |
| BK1310-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 6501.99 fold change |
| BK1310-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 4096.00 fold change |
Secondary
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 361. BK1310 group: due to physician decision (n=1). Control group: due to withdrawal by parent/guardian (n=2), deviation in blood collection timing (n=2), insufficient sample volume (n=4). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1: n=1）
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 933.60 fold change |
| BK1310-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 851.19 fold change |
| BK1310-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 1824.56 fold change |
| BK1310-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 588.13 fold change |
| BK1310-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 1320.32 fold change |
| BK1310-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 1955.52 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 2137.58 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 742.01 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 1430.55 fold change |
| ActHIB® and Tetrabik (Control) | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 885.67 fold change |
| ActHIB® and Tetrabik (Control) | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 1551.43 fold change |
| ActHIB® and Tetrabik (Control) | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 1978.66 fold change |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (diphtheria: n=2）
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Diphtheria Toxin | 1.1640 IU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Diphtheria Toxin | 0.8058 IU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Diphtheria Toxin | 0.8767 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Diphtheria Toxin | 0.7010 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Diphtheria Toxin | 12.9090 IU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Diphtheria Toxin | 10.2457 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Pertussis （FHA） | 122.20 EU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Pertussis （FHA） | 85.52 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (FHA: n=1）
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Pertussis （FHA） | 67.41 EU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Pertussis （FHA） | 49.99 EU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Pertussis （FHA） | 57.59 EU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Pertussis （FHA） | 83.64 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Pertussis （PT） | 230.34 EU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Pertussis （PT） | 223.85 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (PT: n=1）
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Pertussis （PT） | 208.80 EU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Pertussis （PT） | 180.78 EU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Pertussis （PT） | 175.35 EU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Pertussis （PT） | 184.17 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (tetanus: n=1）
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.5320 IU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.4032 IU/mL |
| BK1310 | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.4950 IU/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.2807 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer Against Tetanus Toxin | 1.1670 IU/mL |
| BK1310-Low | Geometric Mean Antibody Titer Against Tetanus Toxin | 1.0640 IU/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer of Anti-PRP Antibody | 69.937 µg/mL |
| BK1310-Low | Geometric Mean Antibody Titer of Anti-PRP Antibody | 54.333 µg/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310-High | Geometric Mean Antibody Titer of Anti-PRP Antibody | 17.613 µg/mL |
| BK1310-Low | Geometric Mean Antibody Titer of Anti-PRP Antibody | 23.097 µg/mL |
| BK1310 | Geometric Mean Antibody Titer of Anti-PRP Antibody | 17.832 µg/mL |
| ActHIB® and Tetrabik (Control) | Geometric Mean Antibody Titer of Anti-PRP Antibody | 6.245 µg/mL |