NCT03370289

A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects

An Open-label Phase 4 Study to Evaluate the Immunogenicity and Safety of Intramuscular Injections of BLB-750 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular vaccinations with BLB-750 in healthy Japanese adults.

Detailed description

The drug being tested in this study is called BLB-750 that is a vaccine for pandemic influenza infection. This study will evaluate immunogenicity and safety of two intramuscular vaccinations with BLB-750 at 3-week intervals in healthy Japanese adults. The study will enroll 55 participants. BLB-750 will be administered in opened manner: \- Two intramuscular vaccinations of BLB-750 at 3-week intervals, 0.5 mL This trial will be conducted in Japan. The overall time to participate in this study will be 43 days, starting on the day of first vaccination. Participants will make multiple visits to the clinic, including 21 days after the first vaccination and 21 days after the second vaccination.

Conditions

• Pandemic Influenza Prevention

Interventions

Type	Name	Description
BIOLOGICAL	BLB-750 Vaccine (Qinghai RG strain)	BLB-750 Injection

Timeline

• Start date: 2018-01-12
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2017-12-12
• Last updated: 2019-07-29
• Results posted: 2019-07-29

Locations

1 site across 1 country: Japan