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NCT03739112 · ClinicalTrials.gov registry record · Phase 3
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
A Phase 3 study, sponsored by Medicago.
- Completed
- Registry status
- Phase 3
- Development phase
- 12,794
- Enrollment target
NCT03739112: Completed Phase 3 study, sponsored by Medicago.
NCT03739112 is a Phase 3 study that has completed, run by Medicago. The registered enrollment target is 12,794 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1559% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03739112, a Phase 3 study, has completed, sponsored by Medicago.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12,794 participants
- Enrollment target
Study Summary
This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.
Primary Outcome
Occurrences of laboratory-confirmed ILI caused by any influenza viral strains was measured by reverse transcriptase polymerase chain reaction (RT-PCR). A participant was considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing and at least one of the following systemic symptoms: fever (defined as a temperature \> 37.2 °C or \> 99.0 °F), chills, tiredness,
Interventions
- BIOLOGICAL Quadrivalent VLP Vaccine
- BIOLOGICAL Fluarix Quadrivalent® Comparator Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,794 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 3 |
What the finished NCT03739112 record still lists
NCT03739112 is an interventional study that assigns participants to a tested intervention. Its 12,794 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1559% higher).
The record links to 0 conditions, and to 2 interventions - of which Quadrivalent VLP Vaccine is the first listed.
NCT03739112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03739112 about?
NCT03739112 is a clinical study titled "Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly". This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain)...
What is the current status of trial NCT03739112?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12,794 participants. The study started on 2018-09-18. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT03739112?
The interventions under investigation include: Quadrivalent VLP Vaccine (BIOLOGICAL), Fluarix Quadrivalent® Comparator Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03739112?
This trial is sponsored by Medicago, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03739112's enrollment target sits among peer trials
12,794 19th of 2000 higher than 1,982 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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