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NCT01290419 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine
A Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT01290419 is a Phase 1 study of Respiratory Syncytial Virus Infections that has completed, run by Novavax. The registered enrollment target is 150 participants, below the 1,084-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01290419, a Phase 1 study of Respiratory Syncytial Virus Infections, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age). Study Objectives: Primary: * To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. Secondary: * To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations * To confirm the "dose sparing" and "value added" effects of the aluminum phosphate adjuvant
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV-F Particle Vaccine
Study Locations (1)
Texas
- Healthcare Discoveries d/b/a ICON Development Solutions - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01290419
The ClinicalTrials.gov registry entry for NCT01290419 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,084-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (86% lower). The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01290419 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01290419 about?
NCT01290419 is a clinical study titled "Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine". A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age). Study Objectives: Primary: * To assess and compare the safety, reactogenicit...
What is the current status of trial NCT01290419?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2010-12. Estimated completion is 2011-12.
What conditions does trial NCT01290419 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT01290419?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV-F Particle Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01290419?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01290419 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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