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)

Summary

The aim of the present dose ranging study is to evaluate the safety, tolerability and immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.

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.

Sponsors & Collaborators

• Novartis Vaccines

  collaborator INDUSTRY

• Seqirus

  lead INDUSTRY

Principal Investigators

• Clinical Scientist · Seqirus

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2009-03-31

Completion

2010-11-30

Countries

• United States
• Germany

Study Locations