NCT00620815 - Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above | Biotech Hunter

Enrollment

601

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

January 31, 2008

Study Completion Date

December 31, 2008

Conditions

Influenza

Interventions

BIOLOGICAL

MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine

Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.

BIOLOGICAL

Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1

Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.

BIOLOGICAL

Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine

Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.

BIOLOGICAL

Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1

Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.

BIOLOGICAL

Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine

Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

BIOLOGICAL

MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine

Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

Trial Locations (2)

80799

International Medicine & Public Health Dept. of Infect. Diseases, Munich

83607

ATRIUM Gesundheitszentrum;, Holzkirchen