NCT05007041

Simultaneous RZV and aIIV4 Vaccination

Safety of Simultaneous Vaccination With Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aIIV4)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pain
• Quality of Life
• Injection Site Reaction
• Adverse Drug Event

Interventions

Type	Name	Description
BIOLOGICAL	FLUAD® Quadrivalent	Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
BIOLOGICAL	Fluzone® High-Dose Quadrivalent	Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
BIOLOGICAL	SHINGRIX®	Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Timeline

• Start date: 2021-09-21
• Primary completion: 2023-03-04
• Completion: 2023-06-08
• First posted: 2021-08-16
• Last updated: 2024-07-11
• Results posted: 2024-05-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study