Confirmatory Study of BK1310 in Healthy Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

September 18, 2019

Study Completion Date

August 10, 2020

Conditions
TetanusDiphtheriaPertussisPoliomyelitisBacterial Meningitis
Interventions
BIOLOGICAL

DPT-IPV-Hib

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

BIOLOGICAL

Hib vaccine

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

BIOLOGICAL

DPT-IPV

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

Trial Locations (1)

Unknown

Investigational Site, Fukuoka

All Listed Sponsors
collaborator

The Research Foundation for Microbial Diseases of Osaka University

OTHER

lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY