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Simultaneous RZV and aIIV4 Vaccination

NCT05007041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2024-07-11

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kenneth Schmader, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2023-03-04
Completion
2023-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05007041 on ClinicalTrials.gov