Simultaneous RZV and aIIV4 Vaccination

  • STATUS
    Not Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    400
  • sponsor
    Duke University
Updated on 13 June 2022

Summary

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.

Description

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.

Details
Condition adverse drug events, Acute Pain Service, drug reaction, ache, quality-of-life, overdose of drug with toxic effect, Injection Site Reaction, Pain (Pediatric), adverse drug reaction, adverse drug reactions, Post-Surgical Pain, Pain, Quality of life, injection site reactions
Treatment Shingrix®, FLUAD® Quadrivalent, Fluzone® HD Quadrivalent
Clinical Study IdentifierNCT05007041
SponsorDuke University
Last Modified on13 June 2022

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