Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Hepatitis B, Haemophilus influenzae type b, Pertussis, Diphtheria, Tetanus, Poliomyelitis, Combination Vaccine, BK1803, Infants
Brief summary
This study is a phase 3, randomized, observer-blinded, active-controlled, multicenter study to evaluate the immunogenicity and safety of BK1803 in healthy infants aged 2 months to less than 7 months. Participants will be randomized to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection. The primary objective is to demonstrate the noninferiority of BK1803 compared with the control in terms of antibody seroprotection rates against hepatitis B surface (HBs) antigen, Haemophilus influenzae type b (Hib), pertussis, diphtheria, tetanus, and poliovirus. Safety will also be assessed throughout the study.
Detailed description
This is a phase 3, randomized, observer-blinded, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of BK1803 in healthy infants. BK1803 is a combined vaccine containing antigens against diphtheria, pertussis, tetanus, inactivated poliovirus, Haemophilus influenzae type b (Hib), and hepatitis B. This study aims to assess whether BK1803 provides immunogenicity comparable to standard vaccination regimens. The study consists of two cohorts: a safety lead-in cohort and a main cohort. In the safety lead-in cohort, participants receive BK1803 to evaluate its initial safety and tolerability before initiating the main cohort. In the main cohort, participants are randomized in a 1:1 ratio to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection. Participants will receive primary and booster immunizations according to the study schedule, and immunogenicity will be evaluated based on antibody responses to multiple vaccine antigens. Safety will be monitored throughout the study period.
Interventions
BIOLOGICALBK1803
BK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.
BIOLOGICALGOBIK Aqueous Suspension Syringes
GOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.
BIOLOGICALBimmugen® Injection
Bimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.
Sponsors
Tanabe Pharma Corporation
The Research Foundation for Microbial Diseases of Osaka University (BIKEN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an observer-blinded study in which outcome assessors are blinded to treatment assignment. Due to differences in administration methods and study procedures, participants and care providers are not blinded. Measures are taken to maintain blinding of outcome assessors, including separation of personnel involved in vaccination and those involved in outcome evaluation.
Intervention model description
Participants are randomized in a 1:1 ratio to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection.
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
Subjects meeting all of the following inclusion criteria at the time of the first vaccination with the study drug will be eligible for study participation. 1. Japanese healthy infants aged \>= 2 months and \< 7 months at the time of the first vaccination with the study drug. However, although subjects meeting the following definition of "subjects who should receive a vaccination with care" may participate in the study, whether or not to enroll them in the study should be decided carefully by the (sub)investigator. 2. Subjects from whose legal guardians (persons with parental rights) written consent to study participation has been obtained. Subjects Who Should Receive A Vaccination With Care 4) applies only to the Main Cohort. 1. Subjects who clearly have underlying diseases, such as cardiovascular disease, kidney disease, liver disease, blood disease, respiratory disease, or a developmental disorder 2. Subjects who have developed a pyrexia within 2 days after receiving a vaccination in the past 3. Subjects with a past history of convulsions 4. (Main Cohort only) Subjects with the gestational age \<37 weeks, or who weighed less than 2500 g at birth
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody seroprotection rates against vaccine antigens in the BK1803 of Main Cohort | 4 weeks from the post-primary immunization of BK1803 in Main Cohort (Visit4) | The antibody seroprotection rates against hepatitis B surface (HBs) antigen, polyribosylribitol phosphate (PRP), Bordetella pertussis (pertussis toxin \[PT\] and filamentous hemagglutinin \[FHA\]), diphtheria toxin, tetanus toxin, and attenuated poliovirus will be evaluated. |
| Antibody seroprotection rates against vaccine antigens for HBs antigen in the Control of Main Cohort | 4 weeks from the post-booster immunization of Bimmugen in Main Cohort (Visit6) | The antibody seroprotection rates against hepatitis B surface (HBs) antigen will be evaluated. |
| The antibody seroprotection rates against vaccine antigens for PRP, PT and FHA, diphtheria toxin, tetanus toxin, and attenuated poliovirus in the Control of Main Cohort | 4 weeks from the post-primary immunization of GOBIK in Main Cohort (Visit4) | The antibody seroprotection rates against polyribosylribitol phosphate (PRP), Bordetella pertussis (pertussis toxin \[PT\] and filamentous hemagglutinin \[FHA\]), diphtheria toxin, tetanus toxin, and attenuated poliovirus will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean antibody titers for HBs antigen | 4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization of BK1803 and the post-booster immunization of BK1803/Bimmugen in Main Cohort (Visit 4,6,8) | Geometric mean antibody titers against hepatitis B surface (HBs) antigen will be evaluated. |
| Geometric mean antibody titers for PRP | 4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8) | Geometric mean antibody titers against PRP will be evaluated. |
| Geometric mean antibody titers for Bordetella pertussis (PT and FHA) | 4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8) | Geometric mean antibody titers against Bordetella pertussis (PT and FHA) will be evaluated. |
| Geometric mean antibody titers for diphtheria toxin | 4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8) | Geometric mean antibody titers against diphtheria toxin will be evaluated. |
| Geometric mean antibody titers for tetanus toxin | 4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8) | Geometric mean antibody titers against tetanus toxin will be evaluated. |
| Geometric mean antibody titers for attenuated poliovirus | 4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8) | Geometric mean antibody titers against attenuated poliovirus will be evaluated. |
| Antibody seroprotection rates against vaccine antigens | 4 weeks from the post-primary and the post-booster of BK1803 in Safety Lead-in Cohort (visit 4and 8); 4 weeks from the post-booster of BK1803/GOBIK in Main Cohort (visit 8) | The antibody seroprotection rates against hepatitis B surface (HBs) antigen, polyribosylribitol phosphate (PRP), Bordetella pertussis (pertussis toxin \[PT\] and filamentous hemagglutinin \[FHA\]), diphtheria toxin, tetanus toxin, and attenuated poliovirus will be evaluated. |
Countries
Japan
Contacts
CONTACTClinical Trials Information Desk
STUDY_DIRECTORGeneral Manager
Tanabe Pharma Corporation
Outcome results
None listed