Influenza, Human Clinical Trial
Official title:
Immunogenicity and Safety of MF59-adjuvanted Trivalent Influenza Vaccine (Fluad) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) in the Elderly: Single Versus Concomitant Vaccination
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. This study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.
During influenza season, concomitant influenza and pneumococcal vaccination would be an
effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults.
However, the immunogenicity and safety of concomitant vaccination need to be further
investigated. There is data on immunogenicity and safety after concomitant administration of
pneumococcal polysaccharide vaccine (PPV) and unadjuvanted influenza vaccine; no
interference was noted between two vaccines. However, there are no data for MF59 adjuvanted
influenza vaccine with pneumococcal vaccine. MF59 only locally reacts for immune response,
so immunogenicity should be assessed for both vaccines injected in same arm versus different
arms.
This study is intended to evaluate the immunogenicity and safety of concomitant
MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal
polysaccharide vaccine (PPV23, Prodiax) vaccination in the elderly subjects aged ≥65 years.
Healthy elderly subjects (N = 424) are randomized in a 1:1:1:1 ratio to receive MF59-aTIV
alone (group 1), MF59-aTIV +PPV23 at different arm (group 2), MF59-aTIV +PPV23 at same arm
(group 3) or PPV23 alone (group 4).
Hemagglutination inhibition (HI) assay and multiplex opsono-phagocytic killing assay (MOPA)
will be used to compare the immunogenicity of each vaccine after single or concomitant
vaccination at pre-vaccination and 1 month post-vaccination. MOPA will be taken for four
serotypes (5, 6B, 18C and 19A).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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