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)
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59; Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.; Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.
Intervention MeSH terms: Vaccines; MF59 oil emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: H5N1 Influenza; Pandemic Flu; MF59 Adjuvant; Cell Culture-Derived; Safety; Immunogenicity; Vaccination; H5N1 influenza pandemic