Dose Ranging Study to Evaluate Immunogenicity and Safety of Adjuvanted or Non-adjuvanted Cell Culture-derived H5N1 Influenza Vaccine in Young Adults (18-40 Years Old)

PHASE1CompletedINTERVENTIONAL
Enrollment

753

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

November 30, 2010

Conditions
Influenza
Interventions
BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59

Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59

Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59

Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59

Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59

Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59

Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59

Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59

Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59

Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59

Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59

Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.

BIOLOGICAL

Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59

Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.

Trial Locations (2)

35392

Universitätsklinikum Gießen und Marburg GmbH, Giessen

77030

Baylor College of Medicine, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Seqirus

INDUSTRY