CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 267 enrolled
Drug / intervention
DPT-IPV-Hib +2 morebiological
Likely dose
DPT-IPV-Hib 0.5mLfrom 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/NCT03891758
NCT03891758Phase 3Completed
CompareCT.gov

Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

Tanabe Pharma Corporation·interventional·Posted Mar 27, 2019·Updated Jan 6, 2026

In Brief

A Phase 3 clinical trial evaluating DPT-IPV-Hib, Hib vaccine, and 1 other intervention for Tetanus and 4 related conditions. Completed, enrolled 267 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial Meningitis
CountriesJapan
CollaboratorsThe Research Foundation for Microbial Diseases of Osaka University

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartApr 1, 2019
Primary CompletionSep 18, 2019
Study CompletionAug 10, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.3 years ago

Interventions

DPT-IPV-Hibbiological

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

Hib vaccinebiological

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

DPT-IPVbiological

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