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Confirmatory Study of BK1310 in Healthy Infants

Primary Purpose

Tetanus, Diphtheria, Pertussis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DPT-IPV-Hib
Hib vaccine
DPT-IPV
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus focused on measuring Haemophilus influenza type b, Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine, Hib, DPT-IPV

Eligibility Criteria

2 Months - 42 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BK1310

ActHIB® and Tetrabik

Arm Description

Outcomes

Primary Outcome Measures

Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus

Secondary Outcome Measures

Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher
Geometric mean antibody titer of anti-PRP antibody
Anti-PRP antibody prevalence rate with 1 μg/mL or higher
Geometric mean antibody titer of anti-PRP antibody
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus
Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus
Adverse events and adverse reactions

Full Information

First Posted
March 24, 2019
Last Updated
November 11, 2020
Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
The Research Foundation for Microbial Diseases of Osaka University
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1. Study Identification

Unique Protocol Identification Number
NCT03891758
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
The Research Foundation for Microbial Diseases of Osaka University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial Meningitis
Keywords
Haemophilus influenza type b, Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine, Hib, DPT-IPV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BK1310
Arm Type
Experimental
Arm Title
ActHIB® and Tetrabik
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
DPT-IPV-Hib
Other Intervention Name(s)
BK1310
Intervention Description
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Intervention Type
Biological
Intervention Name(s)
Hib vaccine
Other Intervention Name(s)
ActHIB®
Intervention Description
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Intervention Type
Biological
Intervention Name(s)
DPT-IPV
Other Intervention Name(s)
Tetrabik
Intervention Description
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Primary Outcome Measure Information:
Title
Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus
Time Frame
4 weeks after the primary immunization (Visit 4)
Secondary Outcome Measure Information:
Title
Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher
Time Frame
4weeks after the primary immunization (Visit 4)
Title
Geometric mean antibody titer of anti-PRP antibody
Time Frame
4weeks after the primary immunization (Visit 4)
Title
Anti-PRP antibody prevalence rate with 1 μg/mL or higher
Time Frame
4weeks after the booster dose (Visit 6)
Title
Geometric mean antibody titer of anti-PRP antibody
Time Frame
4weeks after the booster dose (Visit 6)
Title
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus
Time Frame
4weeks after the primary immunization (Visit 4)
Title
Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus
Time Frame
4weeks after the booster dose (Visit 6)
Title
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus
Time Frame
4weeks after the booster dose (Visit 6)
Title
Adverse events and adverse reactions
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Confirmatory Study of BK1310 in Healthy Infants

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