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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: Completed Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by Novavax.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
This primary outcome will be evaluated through an assessment of the following parameters: * Immediate AEs * Solicited AEs * All SAEs and SNMCs * Vital signs * Laboratory Assessments
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 |
What the finished NCT01290419 record still lists
NCT01290419 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,084-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01290419's enrollment target sits among peer trials
150 15th of 21 higher than 7 of 21 other Respiratory Syncytial Virus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections 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.
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