Influenza Clinical Trial
Official title:
Evaluation of Safety and Reactogenicity of FluBlok, Trivalent Recombinant Influenza Vaccine, and Comparison of the Immunogenicity, Efficacy and Effectiveness of FluBlok to a Licensed Egg-Grown Influenza Vaccine in Adults Aged 50 to 64
The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.
Annual influenza epidemics are associated with serious excess morbidity and mortality,
particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs)
have been shown to reduce hospitalization and death following influenza in this vulnerable
population, but their efficacy is lower than that observed in younger, healthy populations.
In addition, recent studies have questioned the level of effectiveness of TIV in the
elderly, suggesting that cohort studies have overestimated the benefits of immunization with
current TIV formulations in this age group. In view of these considerations, it is widely
accepted that improved and alternative vaccines are needed for control of seasonal and
pandemic influenza.
Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs.
Alternative substrates for vaccine production are desirable in order to reduce the
vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow
for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell
cultures. Advantages of this technique include speed of production, absence of egg protein,
and a highly purified product. Previous studies among healthy younger and older adults have
confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine
times higher than those contained in TIV. Dose-related increases in serum antibody levels
after immunization also were observed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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