A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
157actual
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-13 | actual | When the study began enrolling |
| Primary completion | 2025-09-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-23 | actual | The whole study's end, after follow-up |
| First posted | 2023-12-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Grippe
- Influenza
- Vaccines
Interventions
- Biological: pdmFlu vaccine
- Biological: Placebo
- Biological: Licensed influenza vaccine
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants by age group reporting local reactions
measured For 7 days after vaccination
Percentage of participants by age group reporting systemic events
measured For 7 days after vaccination
Percentage of participants by age group reporting adverse events
measured From vaccination to 4 weeks after each vaccination
Percentage of participants by age group reporting serious adverse events
measured From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
Percentage of participants by age group reporting medically attended adverse events
measured From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
Percentage of participants by age group with abnormal hematology and chemistry laboratory values
measured 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with grading shifts in hematology and chemistry laboratory assessments
measured Between baseline and 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with new clinically significant ECG abnormalities
measured 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
Percentage of participants by age group with new troponin I abnormalities
measured 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination
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