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NCT04622592 · ClinicalTrials.gov registry record · Phase 1
Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles (QVLP) Influenza Vaccine in Adults 65 Years of Age and Older
A Phase 1 study, sponsored by Medicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 209
- Enrollment target
NCT04622592 is a Phase 1 study that has completed, run by Medicago. The registered enrollment target is 209 participants.
The verdict
NCT04622592, a Phase 1 study, has completed, sponsored by Medicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 209 participants
- Enrollment target
Study Summary
This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains. In this study, 3 dose levels (15 μg/strain, 30 μg/strain, and 45 μg/strain) of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant (full and half dose) in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development. Participants participated in this study for up to approximately 13 months, during which the first visit was scheduled for screening (up to 7 days in advance of vaccine administration) and the second visit on Day 0 was scheduled for vaccine administration. Telephone contacts were made on Day 1, Day 8, and monthly (starting after Day 28) until the end of the study for safety assessments, including concomitant medication use review. Blood draws at the clinic site for key safety assessments were made on Day 3, and Day 28 and for key immunogenicity assessments on Day 0, Day 28, Day 182 (6-month follow-up), and Day 365 (12-month follow-up).
Interventions
- BIOLOGICAL Instramuscular vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2022-04-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04622592
The ClinicalTrials.gov registry entry for NCT04622592 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medicago, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Instramuscular vaccine is the first listed.
NCT04622592 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04622592 about?
NCT04622592 is a clinical study titled "Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles (QVLP) Influenza Vaccine in Adults 65 Years of Age and Older". This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains. In th...
What is the current status of trial NCT04622592?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 209 participants. The study started on 2020-11-02. Estimated completion is 2022-04-26.
What interventions are being tested in trial NCT04622592?
The interventions under investigation include: Instramuscular vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04622592?
This trial is sponsored by Medicago, which has 9 total clinical trials registered on ClinicalTrials.gov.
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