Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

PHASE2CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

May 31, 2008

Study Completion Date

October 31, 2008

Conditions
Influenza
Interventions
BIOLOGICAL

H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted

All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.

Trial Locations (1)

1090

University Hospital, Department of Clinical Pharmacology, General Hospital Vienna, Vienna

All Listed Sponsors
lead

Alachua Government Services, Inc.

INDUSTRY

NCT00530660 - Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501) | Biotech Hunter | Biotech Hunter