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Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

NCT03188692 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-06

Study results available
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Summary

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

Conditions

  • Immunization

Interventions

BIOLOGICAL

DPT-IPV-Hib (Combined Vaccine)

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

Sponsors & Collaborators

  • The Research Foundation for Microbial Diseases of Osaka University

    collaborator OTHER

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • General Manager · Tanabe Pharma Corporation

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
43 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-23
Primary Completion
2017-11-02
Completion
2018-08-09

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03188692 on ClinicalTrials.gov