Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus
Secondary Outcome
Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher
Condition
Tetanus
Intervention
DPT-IPV-Hib
Study Arms / Comparison Groups
BK1310
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
267
Start Date
April 1, 2019
Completion Date
August 10, 2020
Primary Completion Date
September 18, 2019
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.
Gender
All
Ages
2 Months - 42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
General Manager, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT03891758
Organization ID
BK1310-J03
Responsible Party
Sponsor
Study Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
The Research Foundation for Microbial Diseases of Osaka University
Study Sponsor
General Manager, Study Director, Mitsubishi Tanabe Pharma Corporation
Verification Date
November 2020