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NCT02608502 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
A Phase 3 study of Respiratory Syncytial Virus (RSV), sponsored by Novavax.
- Completed
- Registry status
- Phase 3
- Development phase
- 11,850
- Enrollment target
- 20
- Study locations
NCT02608502: Completed Phase 3 study of Respiratory Syncytial Virus (RSV), sponsored by Novavax.
NCT02608502 is a Phase 3 study of Respiratory Syncytial Virus (RSV) that has completed, run by Novavax. The registered enrollment target is 11,850 participants, above the 5,679-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02608502, a Phase 3 study of Respiratory Syncytial Virus (RSV), has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11,850 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.
Primary Outcome
Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Conditions Studied
Interventions
- BIOLOGICAL RSV-F Vaccine
- BIOLOGICAL Phosphate Buffer Placebo
Study Locations (20)
Arizona
- Research Site US046 - Mesa
- Research Site US054 - Phoenix
- Research Site US048 - Tempe
California
- Research Site US005 - Anaheim
- Research Site US028 - Redding
- Research Site US064 - San Diego
Kansas
- Research Site US003 - Lenexa
- Research Site US052 - Newton
- Research Site US058 - Wichita
Alabama
- Research Site US062 - Birmingham
- Research Site US061 - Mobile
Georgia
- Research Site US045 - Savannah
- Research Site US013 - Stockbridge
Illinois
- Research Site US069 - Chicago
- Research Site US065 - Peoria
Louisiana
- Research Site US068 - Metairie
- Research Site US039 - Metairie
Idaho
- Research Site US012 - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,850 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT02608502 record still lists
NCT02608502 is an interventional study that assigns participants to a tested intervention. Its 11,850 participants enrollment target places it among the larger protocols in the corpus, above the 5,679-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (109% higher).
The record links to 1 condition, with Respiratory Syncytial Virus (RSV) appearing as the primary indexed condition, and to 2 interventions - of which RSV-F Vaccine is the first listed.
NCT02608502 names 20 study sites across 10 states, led by Arizona, California, Kansas.
Frequently Asked Questions
What is clinical trial NCT02608502 about?
NCT02608502 is a clinical study titled "A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults". The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.
What is the current status of trial NCT02608502?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11,850 participants. The study started on 2015-11. Estimated completion is 2016-12.
What conditions does trial NCT02608502 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus (RSV).
What interventions are being tested in trial NCT02608502?
The interventions under investigation include: RSV-F Vaccine (BIOLOGICAL), Phosphate Buffer Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT02608502?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02608502 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02608502's enrollment target sits among peer trials
11,850 3rd of 11 higher than 9 of 11 other Respiratory Syncytial Virus (RSV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus (RSV) 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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