Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles (QVLP) Influenza Vaccine in Adults 65 Years of Age and Older
Public ClinicalTrials.gov record NCT04622592. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Partially-Blinded, Active Comparator-Controlled, Dose-Ranging, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of an Adjuvanted Seasonal Recombinant Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04622592
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 209 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2020
- Primary completion
- Apr 25, 2022
- Completion
- Apr 25, 2022
- Last update posted
- Jul 20, 2023
2020 – 2022
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Optimal Sites | Huntsville | Alabama | 35802-2569 | — |
| Synexus | Chandler | Arizona | 85224 | — |
| Optimal Sites | San Diego | California | 92108 | — |
| Optimal Sites | Melbourne | Florida | 32934-8172 | — |
| Global AES | Orlando | Florida | 32806 | — |
| Global AES | The Villages | Florida | 32162-7116 | — |
| Optimal Sites | Peoria | Illinois | 61614 | — |
| Synexus | Evansville | Indiana | 47714-7513 | — |
| Optimal Sites | Rockville | Maryland | 20850 | — |
| Vitalink Research | Anderson | South Carolina | 29621 | — |
| Vitalink Research | Columbia | South Carolina | 29204 | — |
| Vitalink Research | Gaffney | South Carolina | 29340 | — |
| Vitalink Research | Union | South Carolina | 29379 | — |
| Optimal Sites | Austin | Texas | 78705-2655 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04622592, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04622592 live on ClinicalTrials.gov.