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NCT05052697 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,158
- Enrollment target
NCT05052697 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 1,158 participants.
The verdict
NCT05052697, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,158 participants
- Enrollment target
Study Summary
This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB) Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either: * 1 of 4 dose levels of mIRV (either A or B Strain), * 1 of 4 dose levels of bIRV (containing both A and B strains), * qIRV (at 1 dose level), or * A licensed quadrivalent influenza vaccine (QIV). At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2: * mIRV encoding A strain at dose level 4, or * mIRV encoding B strain at dose level 4. Substudy B This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age: 2-Visit Schedules * 2 doses of qIRV (at a dose level 1), administered 21 days apart. * 2 doses of licensed QIV, administered 21 days apart (as a control group) * A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart. 1-Visit Schedules * A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2. * A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1. * A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations). * A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3. * 1 dose of lic
Interventions
- BIOLOGICAL QIV
- BIOLOGICAL mIRV
- BIOLOGICAL bIRV AB
- BIOLOGICAL qIRV
- BIOLOGICAL bIRV AA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,158 participants |
| Start Date | 2021-09-13 |
| Est. Completion | 2023-01-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05052697
The ClinicalTrials.gov registry entry for NCT05052697 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which QIV is the first listed.
NCT05052697 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05052697 about?
NCT05052697 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza". This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB) Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and qu...
What is the current status of trial NCT05052697?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,158 participants. The study started on 2021-09-13. Estimated completion is 2023-01-27.
What interventions are being tested in trial NCT05052697?
The interventions under investigation include: QIV (BIOLOGICAL), mIRV (BIOLOGICAL), bIRV AB (BIOLOGICAL), qIRV (BIOLOGICAL), bIRV AA (BIOLOGICAL).
Who is sponsoring clinical trial NCT05052697?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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