Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

September 30, 2007

Study Completion Date

February 29, 2008

Conditions
Influenza
Interventions
BIOLOGICAL

Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation

Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.

Trial Locations (4)

119074

National University Hospital, Singapore

529889

Changi General Hospital, Singapore

Unknown

University of Hong Kong, Queen Mary Hospital, Hong Kong

Chinese University of Hong Kong, Prince of Wales Hospital, Shatin

All Listed Sponsors
lead

Alachua Government Services, Inc.

INDUSTRY

NCT00517517 - Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived) | Biotech Hunter | Biotech Hunter