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NCT00995865 · ClinicalTrials.gov registry record · Phase 1
Trial of Yellow Fever Inactivated Vaccine
A Phase 1 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00995865: Completed Phase 1 study, sponsored by GE Healthcare.
NCT00995865 is a Phase 1 study that has completed, run by GE Healthcare. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00995865, a Phase 1 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled, dose-ranging out-patient study designed to provide the first clinical data on the safety, tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy male and female volunteers, 18-49 years of age. Subjects will receive two inoculations of one of two dose levels of XRX-001 vaccine. A control group will receive placebo. Safety will be determined by the incidence and severity of adverse events in each treatment group and in the combined cohorts in the double blind treatment period up to 42 days post-vaccination. Subjects will also be followed-up at 3, 6 and 12 months to determine severe adverse events (SAEs) and changes in health status. Efficacy will be assessed by neutralizing antibody response to the vaccine. The co-primary immunogenicity endpoints will be the dose-response analysis of seroconversion rates (fourfold or greater increase in neutralizing antibody titer between baseline and Day 42) and of the 50% plaque reduction neutralization test (PRNT50) geometric mean titers (GMT) at Day 42. Secondary immunogenicity endpoints will include: 1. The seroconversion rates and GMT neutralizing antibody titers for all dose groups combined on Days 21 and 42. 2. The reverse cumulative distribution curve of antibody titers on Days 21 and 42 for each dose group and for all dose groups combined 3. The duration of antibody titers displaying the seroconversion rate and GMT across all time-points to Month 12, by treatment group and for both dose groups combined.
Primary Outcome
Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe. After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42. Subjects were to return to the clinic on Days 3, 1
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL XRX-001 Inactivated yellow fever vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00995865 record still lists
NCT00995865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00995865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00995865 about?
NCT00995865 is a clinical study titled "Trial of Yellow Fever Inactivated Vaccine". The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled, dose-ranging out-patient study designed to provide the first clinical data on the safety, tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy male and female volunteers, 18-49 ye...
What is the current status of trial NCT00995865?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-01. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00995865?
The interventions under investigation include: Placebo (BIOLOGICAL), XRX-001 Inactivated yellow fever vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00995865?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00995865's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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