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NCT04169009 · ClinicalTrials.gov registry record · Phase 4

Persistence of Protection by Shingrix

A Phase 4 study of Herpes Zoster, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
105
Enrollment target
1
Study location

NCT04169009 is a Phase 4 study of Herpes Zoster that has completed, run by University of Colorado, Denver. The registered enrollment target is 105 participants, below the 2,167-participant average among 16 other Herpes Zoster trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04169009, a Phase 4 study of Herpes Zoster, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
105 participants
Enrollment target
1
Study location

Study Summary

The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.

Conditions Studied

Interventions

  • BIOLOGICAL Shingrix
  • BIOLOGICAL Zostavax

Study Locations (1)

Colorado

  • Clinical Trials Center at University of Colorado Anschutz Medical Center - Aurora

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2020-07-28
Est. Completion 2024-06-13
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT04169009

The ClinicalTrials.gov registry entry for NCT04169009 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,167-participant average among 16 other Herpes Zoster trials with a reported enrollment target (95% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Herpes Zoster appearing as the primary indexed condition, and to 2 interventions - of which Shingrix is the first listed.

NCT04169009 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT04169009 about?

NCT04169009 is a clinical study titled "Persistence of Protection by Shingrix". The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and pr...

What is the current status of trial NCT04169009?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2020-07-28. Estimated completion is 2024-06-13.

What conditions does trial NCT04169009 study?

This clinical trial studies the following conditions: Herpes Zoster.

What interventions are being tested in trial NCT04169009?

The interventions under investigation include: Shingrix (BIOLOGICAL), Zostavax (BIOLOGICAL).

Who is sponsoring clinical trial NCT04169009?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04169009 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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