CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 370 enrolled
Drug / intervention
DPT-IPV-Hib-High（Combined Vaccine） +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02992925
NCT02992925Phase 3Completed
CompareCT.gov

Phase 3 Study of BK1310 in Healthy Infants

Tanabe Pharma Corporation·interventional·Posted Dec 14, 2016·Updated Jan 6, 2026

In Brief

A Phase 3 clinical trial evaluating DPT-IPV-Hib-High（Combined Vaccine）, DPT-IPV-Hib-Low（Combined Vaccine）, and 2 other interventions for Immunization; Infection. Completed, enrolled 370 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunization; Infection
CountriesJapan
CollaboratorsThe Research Foundation for Microbial Diseases of Osaka University

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 14, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 1, 2017
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.5 years ago

Interventions

DPT-IPV-Hib-High（Combined Vaccine）biological

DPT-IPV-Hib-Low（Combined Vaccine）biological

Hib vaccinebiological

DPT-IPVbiological