A Safety and Immunogenicity Study of IVACFLU-A/H5N1

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

930

Participants

Timeline

Start Date

March 7, 2017

Primary Completion Date

August 29, 2017

Study Completion Date

August 30, 2017

Conditions
Avian Influenza
Interventions
BIOLOGICAL

IVACFLU-A/H5N1 vaccine

Monovalent A/H5N1 influenza vaccine (MIV), whole virion inactivated, purified by sucrose gradient on ultracentrifuge. The vaccine was produced in eggs, inactivated with formaldehyde, and formulated with aluminum hydroxide 0.6 mg/0.5 mL with no preservative.

BIOLOGICAL

Placebo

Includes 4.500mg sodium chloride, 0.685 mg sodium phosphate dibasic dihydrate, and 0.186 mg sodium phosphate monobasic dihydrate.

Trial Locations (2)

Unknown

Phase 3: Hai Phong Provincial Preventive Medicine Center, Haiphong

Phase 2 & 3: Khanh Hoa Provincial Health Department, Nha Trang

All Listed Sponsors
collaborator

National Institute of Hygiene and Epidemiology, Vietnam

OTHER

collaborator

World Health Organization

OTHER

collaborator

Department of Health and Human Services

FED

collaborator

PATH

OTHER

collaborator

FHI 360

OTHER

lead

Institute of Vaccines and Medical Biologicals, Vietnam

INDUSTRY

NCT02612909 - A Safety and Immunogenicity Study of IVACFLU-A/H5N1 | Biotech Hunter | Biotech Hunter