Confirmatory Study of BK1310 in Healthy Infants

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

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