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NCT05374317 · ClinicalTrials.gov registry record · Phase 4

Study of the Safety and Immunogenicity of Reduced Doses of the US Yellow Fever Vaccine

A Phase 4 study of Yellow Fever Vaccination Reaction, sponsored by US Army Medical Research Institute of Infectious Diseases.

Completed
Registry status
Phase 4
Development phase
88
Enrollment target
1
Study location

NCT05374317: Completed Phase 4 study of Yellow Fever Vaccination Reaction, sponsored by US Army Medical Research Institute of Infectious Diseases.

NCT05374317 is a Phase 4 study of Yellow Fever Vaccination Reaction that has completed, run by US Army Medical Research Institute of Infectious Diseases. The registered enrollment target is 88 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05374317, a Phase 4 study of Yellow Fever Vaccination Reaction, has completed, sponsored by US Army Medical Research Institute of Infectious Diseases.

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

Study Summary

This is an open-label, randomized, exploratory study to evaluate the human immune response to reduced subcutaneous (SQ) dosing of Yellow Fever vaccine compared to the standard FDA approved subcutaneous vaccination dose. The current dose of the US FDA licensed Yellow Fever vaccine is approximately 55,000 plaque-forming unit(s) (PFU) in 0.5 mL administered SQ. Using the licensed dosage as standard, investigators are evaluating reduced doses of 1/5th (0.10 mL) and 1/10th (0.05 mL) Yellow Fever vaccine (YF-VAX).

Primary Outcome

Rate of Adverse Events of fractional doses vs standard dose of YF-VAX.

Interventions

  • BIOLOGICAL Yellow Fever Vaccine

Study Locations (1)

Maryland

  • United States Army Medical Research Institute of Infectious Diseases - Frederick

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2021-06-07
Est. Completion 2022-11-02
Phase Phase 4

What the finished NCT05374317 record still lists

NCT05374317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Yellow Fever Vaccination Reaction appearing as the primary indexed condition, and to 1 intervention - of which Yellow Fever Vaccine is the first listed.

NCT05374317 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT05374317 about?

NCT05374317 is a clinical study titled "Study of the Safety and Immunogenicity of Reduced Doses of the US Yellow Fever Vaccine". This is an open-label, randomized, exploratory study to evaluate the human immune response to reduced subcutaneous (SQ) dosing of Yellow Fever vaccine compared to the standard FDA approved subcutaneous vaccination dose. The current dose of the US FDA licensed Yellow Fever vaccine is approximately 55...

What is the current status of trial NCT05374317?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2021-06-07. Estimated completion is 2022-11-02.

What conditions does trial NCT05374317 study?

This clinical trial studies the following conditions: Yellow Fever Vaccination Reaction.

What interventions are being tested in trial NCT05374317?

The interventions under investigation include: Yellow Fever Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT05374317?

This trial is sponsored by US Army Medical Research Institute of Infectious Diseases, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05374317 being conducted?

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

How this trial's enrollment target compares

Where NCT05374317's enrollment target sits among peer trials

88 916th of 2000 higher than 1,078 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05374317, the US trial registry maintained by the National Library of Medicine. NCT05374317 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.