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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: Completed Phase 1 study, sponsored by Pfizer.
NCT05052697 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 1,158 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1830% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (\>) 2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) a
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 |
What the finished NCT05052697 record still lists
NCT05052697 is an interventional study that assigns participants to a tested intervention. Its 1,158 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1830% higher).
The record links to 0 conditions, and to 5 interventions - of which QIV is the first listed.
NCT05052697 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05052697's enrollment target sits among peer trials
1,158 5th of 2000 higher than 1,996 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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