Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

NCT ID: NCT03188692

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-23
• Study Completion Date: 2018-08-09

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

Conditions

Immunization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BK1310

Group Type: EXPERIMENTAL

DPT-IPV-Hib (Combined Vaccine)

Intervention Type: BIOLOGICAL

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

Interventions

DPT-IPV-Hib (Combined Vaccine)

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

Intervention Type: BIOLOGICAL

Other Intervention Names

BK1310

Eligibility Criteria

Inclusion Criteria

• Healthy infants aged ≥2 and <43 months at the first vaccination of the study drug (recommended: ≥2 and <7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
• Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria

• With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
• Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
• Possibility of anaphylaxis due to food or pharmaceuticals
• With diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
• With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
• With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
• Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
• Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
• Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)
• Participated in other studies within 12 weeks before obtaining consent
• With the gestational age <37 weeks or weighed less than 2500 grams at birth.
• Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 43 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Research Foundation for Microbial Diseases of Osaka University

OTHER

Sponsor Role: collaborator

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

Investigational site 1

Chiba, , Japan

Investigational site 2

Tokyo, , Japan

Investigational site 3

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BK1310-J02

Identifier Type: -

Identifier Source: org_study_id