CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
DPT-IPV-Hib (Combined Vaccine)biological
Likely dose
DPT-IPV-Hib (Combined Vaccine) 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/NCT03188692
NCT03188692Phase 3Completed
CompareCT.gov

Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants

Tanabe Pharma Corporation·interventional·Posted Jun 15, 2017·Updated Jan 6, 2026

In Brief

A Phase 3 clinical trial evaluating DPT-IPV-Hib (Combined Vaccine) for Immunization. Completed, enrolled 33 participants across 3 sites.

Detailed Summary

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

Study Details

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

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 15, 2017
Enrollment StartJun 23, 2017
Primary CompletionNov 2, 2017
Study CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.0 years ago

Interventions

DPT-IPV-Hib (Combined Vaccine)biological

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