Pain Clinical Trial
Official title:
Safety of Simultaneous Vaccination With Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aIIV4)
The overall aim of the study is to compare the safety of simultaneous RZV (SHINGRIX®) and inactivated adjuvanted influenza vaccine aIIV4 (FLUAD®) versus simultaneous RZV (SHINGRIX®) and inactivated influenza HD-IIV4 (Fluzone® HD) vaccine in persons ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, and 180 older adults at Johns Hopkins University Medical Center. Eligible subjects will be randomized to receive either simultaneous RZV/aIIV4 or RZV/HD-IIV4 vaccines. All subjects will be assessed for 7 days post-injection and safety and tolerability compared between the two groups. Serious adverse events and adverse events of clinical interest will be assessed 42 days post-vaccination and compared between the two groups. Health-related quality of life will be assessed pre-vaccination Day 1 through Day 8.
Intention-to-Treat (ITT) Population: Defined as all subjects who are randomized and vaccinated. Modified Intention-to-Treat (mITT) Population: Defined as all subjects who are randomized, vaccinated, and provide at least one day of complete data on the symptom diary. ;
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