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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 is a Phase 1 study that has completed, run by GE Healthcare. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00995865
The ClinicalTrials.gov registry entry for NCT00995865 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00995865 reports 0 study locations.
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.
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