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pdmFlu vaccine

Phase 1

Grippe | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Feb 23, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment157

FDA Designations

No designations recorded

Clinical trial landscape

pdmFlu vaccine · 1 trial · 3 indications

Phase 1 1
NCT06179446A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic InfluenzaGrippe
COMPLETED157 Analytics
PHASE1COMPLETED
A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza
GrippeUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants by age group reporting local reactions
For 7 days after vaccination
Percentage of participants by age group reporting systemic events
For 7 days after vaccination
Percentage of participants by age group reporting adverse events
From vaccination to 4 weeks after each vaccination
Percentage of participants by age group reporting serious adverse events
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
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
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
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
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
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

Secondary Endpoints

Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination
Proportion of participants by age group achieving HAI seroconversion
At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
pdmFlu vaccine 1EXPERIMENTAL -
pdmFlu vaccine 2EXPERIMENTAL -
pdmFlu vaccine 3EXPERIMENTAL -
pdmFlu vaccine 4EXPERIMENTAL -
pdmFlu vaccine 5EXPERIMENTAL -
pdmFlu vaccine 6EXPERIMENTAL -
pdmFlu vaccine 7EXPERIMENTAL -
pdmFlu vaccine 8EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Licensed influenza vaccineACTIVE_COMPARATOR -

Interventions

NameTypeDescription
pdmFlu vaccineBIOLOGICALIntramuscular injection
PlaceboBIOLOGICALIntramuscular injection
Licensed influenza vaccineBIOLOGICALIntramuscular injection
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Eligibility Criteria

Age Range18 Years to 84 Years
SexALL
Healthy VolunteersYes
Study Sites3

Key Inclusion Criteria: \- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Key Exclusion Criteria: \- Does not meet seasonal influenza vaccine requirements per coho...

Countries:United States
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Frequently asked questions about pdmFlu vaccine

What is the pdmFlu vaccine used for?

The pdmFlu vaccine is an investigational modified RNA vaccine being studied for the prevention of pandemic influenza, referred to in the trial as Grippe. It is designed to produce an immune response against pandemic flu strains. The vaccine is currently in Phase 1 clinical development and is not yet approved.

Who makes the pdmFlu vaccine?

The pdmFlu vaccine is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is conducting clinical research on this modified RNA vaccine candidate for pandemic influenza prevention.

What phase is the pdmFlu vaccine in?

The pdmFlu vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under study for safety and immune response.

What clinical trials is the pdmFlu vaccine in?

The pdmFlu vaccine was studied in a Phase 1 clinical trial registered as NCT06179446, titled 'A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza.' The trial enrolled 157 participants in the United States and has been completed.

Is the pdmFlu vaccine a monoclonal antibody?

No, the pdmFlu vaccine is not a monoclonal antibody. Although the modality is listed as monoclonal antibody in some records, the clinical trial describes it as a modified RNA vaccine. The vaccine is designed to elicit an immune response against pandemic influenza.

Was the pdmFlu vaccine trial randomized and blinded?

Yes, the Phase 1 clinical trial for the pdmFlu vaccine was randomized, double-blind, and placebo-controlled. The study enrolled healthy volunteers aged 18 years and older in the United States, with a total of 157 participants.