NCT00462215 - Phase 3 Immunogenicity and Safety Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived) | Biotech Hunter

Enrollment

550

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

June 30, 2007

Study Completion Date

February 28, 2010

Conditions

Influenza

Interventions

BIOLOGICAL

Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Vietnam/1203/2004

BIOLOGICAL

Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Vietnam/1203/2004

BIOLOGICAL

Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Indonesia/05/2005

BIOLOGICAL

Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Indonesia/05/2005

BIOLOGICAL

Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 12-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain

BIOLOGICAL

Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 24-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain

Trial Locations (2)

1090

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

55101

University Hospital Mainz, Mainz