Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

June 23, 2017

Primary Completion Date

November 2, 2017

Study Completion Date

August 9, 2018

Conditions
Immunization
Interventions
BIOLOGICAL

DPT-IPV-Hib (Combined Vaccine)

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

Trial Locations (3)

Unknown

Investigational site 1, Chiba

Investigational site 2, Tokyo

Investigational site 3, Tokyo

All Listed Sponsors
collaborator

The Research Foundation for Microbial Diseases of Osaka University

OTHER

lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY