Study of BK1803 in Healthy Infants
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-6
SponsorTanabe Pharma Corporation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Subjects from whose legal guardians (persons with parental rights) written consent to study participation has been obtained.
Subjects who clearly have underlying diseases, such as cardiovascular disease, kidney disease, liver disease, blood disease, respiratory disease, or a developmental disorder
Subjects who have developed a pyrexia within 2 days after receiving a vaccination in the past
Disqualifiers
Subjects who have received diagnoses of immunodeficiencies in the past, or who are currently receiving treatments that cause immunosuppression
Subjects with close relatives (up to third degree of kinship) who have a congenital immunodeficiency
Subjects who might experience a serious allergy in response to a food, drug product (especially any component of the study drug), etc.
Subjects who have had Haemophilus Influenzae type b (Hib) infections, pertussis, diphtheria, tetanus, acute poliomyelitis, or hepatitis B in the past
Trial design
Design model
Parallel
Treatments tested in this trial
BK1803
Biological/VaccineBK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.
GOBIK Aqueous Suspension Syringes
Biological/VaccineGOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.
Bimmugen® Injection
Biological/VaccineBimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.
Treatment groups
344 Participants
are divided into 3 treatment groupsGroup A: Safety Lead-in Cohort: BK1803Experimental treatment 1 intervention
Group B: Main Cohort: BK1803Experimental treatment 1 intervention
Group C: Main Cohort: Control (GOBIK and Bimmugen)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Antibody seroprotection rates against vaccine antigens in the BK1803 of Main Cohort
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.
Time frame
4 weeks from the post-primary immunization of BK1803 in Main Cohort (Visit4)2
Antibody seroprotection rates against vaccine antigens for HBs antigen in the Control of Main Cohort
The antibody seroprotection rates against hepatitis B surface (HBs) antigen will be evaluated.
Time frame
4 weeks from the post-booster immunization of Bimmugen in Main Cohort (Visit6)3
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
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.
Time frame
4 weeks from the post-primary immunization of GOBIK in Main Cohort (Visit4)Secondary outcomes
1
Geometric mean antibody titers for HBs antigen
Geometric mean antibody titers against hepatitis B surface (HBs) antigen will be evaluated.
Time frame
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)2
Geometric mean antibody titers for PRP
Geometric mean antibody titers against PRP will be evaluated.
Time frame
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)3
Geometric mean antibody titers for Bordetella pertussis (PT and FHA)
Geometric mean antibody titers against Bordetella pertussis (PT and FHA) will be evaluated.
Time frame
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)4
Geometric mean antibody titers for diphtheria toxin
Geometric mean antibody titers against diphtheria toxin will be evaluated.
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tanabe Pharma Corporation
Lead sponsor
The Research Foundation for Microbial Diseases of Osaka University (BIKEN)
Collaborator
Source ClinicalTrials.gov
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