The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters associated with improved protection against clinical disease in elderly. Such parameters include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune response. Vaccination will start in 22 healthy adults receiving the investigational vaccine. Vaccination of elderly will be initiated only after demonstration of safety in adults. 88 healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza vaccine alone and 44 will receive the investigational vaccine. Vaccines will be administrated intramuscularly in the upper arm. One dose will be administered to each volunteer included in the study. Blood samples for basic immunological assessments of cellular and humoral immunity will be taken at day 0, 7, 28, 90 and 150. The investigational vaccine is equal to one standard human dose of a commercial seasonal influenza vaccine to which 50 µg of adjuvant Matrix M has been added.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
110
1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M, total dosage volume 0.55 mL injected intramuscularly in the upper arm once at day 0.
1 human dose of seasonal influenza vaccine
Drug Reseach Center
Balatonfüred, Balatonfured, Hungary
Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M
Time frame: 1 - 3 months
Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M
Time frame: 1 - 7 months
Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M
Time frame: 1 - 7 months
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