Influenza Clinical Trial
Official title:
A Phase I Single Blinded Randomised Exploratory Trial in Elderly Volunteers to Assess and Compare Safety and Immunogenicity of Adjuvanted Seasonal Influenza Vaccine (Investigational Vaccine) to Standard Seasonal Influenza Vaccine.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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