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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing a new vaccine called Pandemic Influenza modRNA (pdmFlu) Vaccine to see if it can prevent the flu. They are looking for participants between the ages
Who is the study for?
This trial is for healthy adults aged 18 to 49 who can commit to the study's schedule and procedures. They must not have received any flu vaccine in the past 6 months and should be able to give informed consent.
What is being tested?
The trial is testing a new mRNA vaccine for pandemic influenza, comparing it with a licensed quadrivalent influenza vaccine (QIV) and a placebo. Participants will get shots on day 1 and day 21 without knowing which one they receive.
What are the potential side effects?
Potential side effects may include pain at the injection site, fever, fatigue, headache, muscle pains similar to those experienced with other vaccines but specific risks of pdmFlu Vaccine will be studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 4 trial • 267 Patients • NCT050070418%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: pdmFlu vaccine dose CExperimental Treatment1 Intervention
Group II: pdmFlu vaccine dose BExperimental Treatment1 Intervention
Group III: pdmFlu vaccine dose AExperimental Treatment1 Intervention
Group IV: Licensed influenza vaccineActive Control1 Intervention
Group V: PlaceboPlacebo Group1 Intervention
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,625 Previous Clinical Trials
14,284,094 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,670 Total Patients Enrolled
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