Confirmatory Study of BK1310 in Healthy Infants

Sponsor

Mitsubishi Tanabe Pharma Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03891758

Collaborator

The Research Foundation for Microbial Diseases of Osaka University (Other)

267

Enrollment

Location

Arms

16.3

Actual Duration (Months)

16.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tetanus Diphtheria Pertussis Poliomyelitis Bacterial Meningitis	Biological: DPT-IPV-Hib Biological: Hib vaccine Biological: DPT-IPV	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

267 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Sep 18, 2019

Actual Study Completion Date :

Aug 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BK1310	Biological: DPT-IPV-Hib 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. Other Names: BK1310
Active Comparator: ActHIB® and Tetrabik	Biological: Hib vaccine 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. Other Names: ActHIB® Biological: DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. Other Names: Tetrabik

Arm

Intervention/Treatment

Experimental: BK1310

Biological: DPT-IPV-Hib

0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Other Names:

BK1310

Active Comparator: ActHIB® and Tetrabik

Biological: Hib vaccine

0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Other Names:

ActHIB®

Biological: DPT-IPV

0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Other Names:

Tetrabik

Outcome Measures

Primary Outcome Measures

Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus [4 weeks after the primary immunization (Visit 4)]

Secondary Outcome Measures

Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [4weeks after the primary immunization (Visit 4)]
Geometric mean antibody titer of anti-PRP antibody [4weeks after the primary immunization (Visit 4)]
Anti-PRP antibody prevalence rate with 1 μg/mL or higher [4weeks after the booster dose (Visit 6)]
Geometric mean antibody titer of anti-PRP antibody [4weeks after the booster dose (Visit 6)]
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus [4weeks after the primary immunization (Visit 4)]
Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus [4weeks after the booster dose (Visit 6)]
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus [4weeks after the booster dose (Visit 6)]
Adverse events and adverse reactions [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 42 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.