Clinical trial NCT03891758: Confirmatory Study of BK1310 in Healthy Infants
Official title: Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Diphtheria
Pertussis
Poliomyelitis
Bacterial Meningitis
Keywords: Haemophilus influenza type b
Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine
Hib
DPT-IPV
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: The Research Foundation for Microbial Diseases of Osaka University
First posted: 2019-03-27
Enrollment: 267
Sex: ALL
Minimum age (years): 2
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.


Eligibility criteria: Inclusion Criteria:

* Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months)
* Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

* 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.
* Participated in other studies within 12 weeks before obtaining consent
* Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment

Additional screening criteria check may apply for qualification.

Primary outcomes:
measure: 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
timeFrame: 4 weeks after the primary immunization (Visit 4)
Secondary outcomes:
measure: Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer of Anti-PRP Antibody
timeFrame: 4weeks after the primary immunization (Visit 4)
measure: Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer of Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Diphtheria Toxin
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Pertussis
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Tetanus Toxin
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Polio Virus
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: 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
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Diphtheria Toxin
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Pertussis
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Tetanus Toxin
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Fold Change in Geometric Mean Antibody Titer Against Polio Virus
timeFrame: Baseline and 4 weeks after the primary immunization (Visit 6)
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Investigational Site
state: Fukuoka
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References:
citation: Nakano T, Hasegawa M, Endo M, Matsuda K, Tamai H. Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants >/= 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Vaccine. 2024 Apr 30;42(12):3134-3143. doi: 10.1016/j.vaccine.2023.03.077. Epub 2024 Apr 6.