At a glance
ClinicalIndex Comparison Record- ✓Age 65 years or older
- ✓Intention to receive both influenza and recombinant zoster vaccines per CDC-ACIP guidelines
- ✓Able to speak English and provide written informed consent
- ✓Living in the community and available for entire study period including follow-up phone calls and clinic visits
- ✕Prior receipt of influenza vaccine (IIV or RIV) during 2021-2022 or 2022-2023 season before enrollment
- ✕Prior receipt of Shingrix (recombinant zoster vaccine)
- ✕Acute illness or exacerbation of chronic illness within 72 hours of study vaccination
- ✕Hospitalization within the last 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety of Simultaneous Vaccination With Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aIIV4)
In Brief
A Phase 4 clinical trial evaluating FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent, and 1 other intervention for Pain and 3 related conditions. Completed, enrolled 267 participants across 2 sites.
Detailed Summary
The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vaccine in persons age ≥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/FLUAD® or RZV/Fluzone® High-Dose 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. Serious Adverse Events and Adverse Events of Clinical Interest were also assessed throughout the study period.
Study Details
Timeline
Interventions
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine