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Vaccine

Recombinant Zoster Vaccine (RZV) and high-dose quadrivalent influenza vaccine for Quality of Life

Phase 4

Waitlist Available

Led By Kenneth Schmader, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up 42 days post-vaccination

Awards & highlights

Study Summary

This trial will compare the safety of two different influenza vaccines given with the shingles vaccine. Approximately 400 older adults will be enrolled at two medical centers. Subjects will be randomized to receive either the aIIV4 or 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.

Eligible Conditions

Quality of Life
Injection Site Reaction
Adverse Drug Reactions
Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up 42 days post-vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up 42 days post-vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and up 42 days post-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after SHINGRIX® dose 1 in each study group

Secondary outcome measures

Number of participants with at least one serious adverse event or adverse event of clinical interest after SHINGRIX® dose 1 in each study group

Number of participants with at least one severe (Grade 3) solicited local reactogenicity event after SHINGRIX® dose 1 in each study group

Number of participants with at least one severe (Grade 3) solicited systemic reactogenicity after SHINGRIX® dose 1 in each study group

Trial Design

2Treatment groups

Active Control

Group I: Recombinant Zoster Vaccine (RZV) and high-dose quadrivalent influenza vaccineActive Control2 Interventions

In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.

Group II: Recombinant Zoster Vaccine (RZV) and Quadrivalent adjuvanted influenza vaccineActive Control2 Interventions

In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the quadrivalent adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER

2,259 Previous Clinical Trials

14,820,386 Total Patients Enrolled

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,135 Total Patients Enrolled

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,419,802 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment pioneering in its approach?

"At this time, there are 28 international trials for Recombinant Zoster Vaccine (RZV) and Quadrivalent adjuvanted influenza vaccine taking place across 23 distinct nations. These clinical studies began in 2014 when Bristol-Myers Squibb sponsored its Phase 2 drug approval stage; it included 130 participants. Over the course of 6 years, 214 tesitng events have happened."

Answered by AI

What other scientific experiments have been done to examine the effects of Recombinant Zoster Vaccine (RZV) and Quadrivalent adjuvanted influenza vaccine?

"A total of 28 investigations are being conducted on the efficacy and safety of Recombinant Zoster Vaccine (RZV) and Quadrivalent adjuvanted influenza vaccine, with 5 having reached Phase 3. Across 220 different medical centres, mostly located in Aurora Colorado, these trials are actively enrolling patients."

Answered by AI

How many individuals are participating in this experiment?

"Confirmed. According to the details found on clinicaltrials.gov, this trial is accepting new participants at present. The study was initially posted on September 21st 2021 and has since been adjusted as recently as September 13th 2022. Currently, 400 patients are being recruited from 1 specific site."

Answered by AI

Are there vacancies remaining in this clinical investigation?

"According to the clinicaltrials.gov, this medical trial is currently seeking participants having been posted on September 21st 2021 and most recently updated on September 13th 2022."

Answered by AI

What effects can be expected from the administration of Recombinant Zoster Vaccine (RZV) and Quadrivalent adjuvanted influenza vaccine?

"Our staff at Power assigned a grade of 3 on a 1-3 scale to the safety profile of RZV and Quadrivalent adjuvanted influenza vaccine, as this is an approved Phase 4 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Simultaneous RZV and aIIV4 Vaccination

2021. "Simultaneous RZV and aIIV4 Vaccination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05007041.