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NCT03301051 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults
A Phase 3 study of Influenza and Respiratory Tract Infections, sponsored by Medicago.
- Completed
- Registry status
- Phase 3
- Development phase
- 10,160
- Enrollment target
- 20
- Study locations
NCT03301051: Completed Phase 3 study of Influenza and Respiratory Tract Infections, sponsored by Medicago.
NCT03301051 is a Phase 3 study of Influenza and Respiratory Tract Infections that has completed, run by Medicago. The registered enrollment target is 10,160 participants, below the 36,739-participant average among 156 other Influenza trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301051, a Phase 3 study of Influenza and Respiratory Tract Infections, has completed, sponsored by Medicago.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10,160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 participants
Primary Outcome
Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. O
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Quadrivalent VLP Vaccine
Study Locations (20)
Florida
- Site 217 - Coral Gables
- Site 220 - Hollywood
- Site 212 - South Miami
North Carolina
- Site 216 - Charlotte
- Site 221 - Charlotte
- Site 227 - Winston-Salem
Georgia
- Site 203 - Savannah
- Site 218 - Stockbridge
Nebraska
- Site 224 - Norfolk
- Site 208 - Omaha
New York
- Site 205 - Binghamton
- Site 228 - Endwell
Alabama
- Site 222 - Mobile
California
- Site 210 - Anaheim
Connecticut
- Site 223 - Milford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,160 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2018-05-09 |
| Phase | Phase 3 |
What the finished NCT03301051 record still lists
NCT03301051 is an interventional study that assigns participants to a tested intervention. Its 10,160 participants enrollment target places it among the larger protocols in the corpus, below the 36,739-participant average among 156 other Influenza trials with a reported enrollment target (72% lower).
The record links to 5 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03301051 names 20 study sites across 13 states, led by Florida, North Carolina, Georgia.
Frequently Asked Questions
What is clinical trial NCT03301051 about?
NCT03301051 is a clinical study titled "Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults". This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 part...
What is the current status of trial NCT03301051?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10,160 participants. The study started on 2017-08-31. Estimated completion is 2018-05-09.
What conditions does trial NCT03301051 study?
This clinical trial studies the following conditions: Influenza, Respiratory Tract Infections, Respiratory Tract Diseases, Virus Diseases, RNA Virus Infections.
What interventions are being tested in trial NCT03301051?
The interventions under investigation include: Placebo (BIOLOGICAL), Quadrivalent VLP Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03301051?
This trial is sponsored by Medicago, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03301051 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03301051's enrollment target sits among peer trials
10,160 12th of 156 higher than 145 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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