Influenza Clinical Trial
Official title:
Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
The aim of the study is to generate data on key parameters associated with assessment of
influenza vaccines in individuals 50-64 years of age
Primary Objective:
- To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine
(TIV) compared to TIV.
- To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as
assessed by solicited adverse reactions collected for 7 days post-vaccination, and
unsolicited adverse events (including Serious Adverse Events and Adverse Events of
Special Interests) collected between Visit 1 and Visit 2
Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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