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Confirmatory Study of BK1310 in Healthy Infants

NCT03891758 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2026-01-06

Study results available
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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.

Conditions

  • Tetanus
  • Diphtheria
  • Pertussis
  • Poliomyelitis
  • Bacterial Meningitis

Interventions

BIOLOGICAL

DPT-IPV-Hib

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

BIOLOGICAL

Hib vaccine

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

BIOLOGICAL

DPT-IPV

0.5mL, subcutaneous 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
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-09-18
Completion
2020-08-10

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 NCT03891758 on ClinicalTrials.gov