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NCT06436703 · ClinicalTrials.gov registry record · Phase 1
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,202
- Enrollment target
NCT06436703: Completed Phase 1 study, sponsored by Pfizer.
NCT06436703 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 1,202 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1903% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06436703, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,202 participants
- Enrollment target
Study Summary
The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are: * safe; and * how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign. RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid. Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat. The study is seeking for participants who: * are at least 18 years of age * have not received an influenza vaccine within the last 6 months * are generally healthy This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC). All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm: * 1 of the modRNA influenza vaccines that is being studied; or * an approved influenza vaccine approved for use in their respective age group. Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.
Primary Outcome
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any
Interventions
- BIOLOGICAL Influenza ModRNA Vaccine
- BIOLOGICAL Quadrivalent Influenza Vaccine (QIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,202 participants |
| Start Date | 2024-05-23 |
| Est. Completion | 2025-02-05 |
| Phase | Phase 1 |
What the finished NCT06436703 record still lists
NCT06436703 is an interventional study that assigns participants to a tested intervention. Its 1,202 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 (1903% higher).
The record links to 0 conditions, and to 2 interventions - of which Influenza ModRNA Vaccine is the first listed.
NCT06436703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06436703 about?
NCT06436703 is a clinical study titled "A Study About Modified RNA Vaccines Against Influenza in Healthy Adults". The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are: * safe; and * how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign. RN...
What is the current status of trial NCT06436703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,202 participants. The study started on 2024-05-23. Estimated completion is 2025-02-05.
What interventions are being tested in trial NCT06436703?
The interventions under investigation include: Influenza ModRNA Vaccine (BIOLOGICAL), Quadrivalent Influenza Vaccine (QIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06436703?
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 NCT06436703's enrollment target sits among peer trials
1,202 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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