Simultaneous RZV and aIIV4 Vaccination

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.

Timeline

Start

2021-09-21

Primary completion

2023-03-04

Completion

2023-06-08

Publications

• Schmader KE, Walter EB, Talaat KR, Rountree W, Poniewierski M, Randolph E, Leng SX, Wunderlich B, McNeil MM, Museru O, Broder KR. Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2440817. doi: 10.1001/jamanetworkopen.2024.40817.
• de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

Drugs

Indications

No indication recorded.