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Phase 3 Study of BK1310 in Healthy Infants

NCT02992925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-01-06

Study results available
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Summary

The purpose of this study is to:

* (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
* (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

Conditions

  • Immunization; Infection

Interventions

BIOLOGICAL

DPT-IPV-Hib-High（Combined Vaccine）

BIOLOGICAL

DPT-IPV-Hib-Low（Combined Vaccine）

BIOLOGICAL

Hib vaccine

BIOLOGICAL

DPT-IPV

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
43 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-12-31
Completion
2018-11-30

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 NCT02992925 on ClinicalTrials.gov