A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza

Study Overview
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Brief Summary
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The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine. This study is seeking for participants who are: between the age of 18 to 49 years old. willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures. healthy as confirmed by medical history, physical examinations, and the study doctor. capable of signing informed consent. Participants will receive either: the pdmFlu Vaccine, a licensed Influenza Vaccine (QIV) a placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm at day 1 and at day 21. The study will compare participant experiences to help understand if the pdmFlu Vaccine is safe and effective. Participants will take part in this study for up to 8 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.

Official Title
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A PHASE 1, RANDOMIZED, OBSERVER-BLIND, DOSE-RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST PANDEMIC INFLUENZA IN HEALTHY INDIVIDUALS 18 THROUGH 49 YEARS OF AGE

Conditions
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Grippe, Influenza, Vaccines

Intervention / Treatment
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* Biological: PF-07985819 pdmFlu Vaccine
* Biological: Placebo
* Biological: Quadrivalent influenza vaccine (QIV)


Participation Criteria
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Eligibility Criteria
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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: - Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-07985819 pdmFlu vaccine dose A<br> | Biological: PF-07985819 pdmFlu Vaccine<br>* Intramuscular injection<br>|
| Experimental: PF-07985819 pdmFlu vaccine dose B<br> | Biological: PF-07985819 pdmFlu Vaccine<br>* Intramuscular injection<br>|
| Experimental: PF-07985819 pdmFlu Vaccine dose C<br> | Biological: PF-07985819 pdmFlu Vaccine<br>* Intramuscular injection<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Intramuscular injection<br>|
| Active Comparator: Quadrivalent influenza vaccine (QIV)<br> | Biological: Quadrivalent influenza vaccine (QIV)<br>* Intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants reporting local reactions |  | For 7 days after vaccination | 
| Percentage of participants reporting systemic events |  | For 7 days after vaccination | 
| Percentage of participants reporting adverse events |  | From vaccination to 4 weeks after last vaccination | 
| Percentage of participants reporting serious adverse events |  | From vaccination to 6 months after last vaccination | 
| Percentage of participants with abnormal hematology and chemistry laboratory values |  | 1 week after vaccination 1 | 
| Percentage of participants with abnormal hematology and chemistry laboratory values |  | 3 weeks after vaccination 1 | 
| Percentage of participants with abnormal hematology and chemistry laboratory values |  | 1 week after vaccination 2 | 
| Percentage of participants with abnormal hematology and chemistry laboratory values |  | 4 weeks after vaccination 2 | 
| Percentage of participants with grading shifts in hematology and chemistry laboratory assessments |  | Between baseline and 1 week after vaccination 1 | 
| Percentage of participants with grading shifts in hematology and chemistry laboratory assessments |  | Between baseline and 3 weeks after vaccination 1 | 
| Percentage of participants with grading shifts in hematology and chemistry laboratory assessments |  | Between baseline and 1 week after vaccination 2 | 
| Percentage of participants with grading shifts in hematology and chemistry laboratory assessments |  | Between baseline and 4 weeks after vaccination 2 | 
| Percentage of participants with new electrocardiogram (ECG) abnormalities |  | 1 week after vaccination 1 | 
| Percentage of participants with new ECG abnormalities |  | 3 weeks after vaccination 1 | 
| Percentage of participants with new ECG abnormalities |  | 1 week after vaccination 2 | 
| Percentage of participants with new ECG abnormalities |  | 4 weeks after vaccination 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers |  | At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2 | 
| Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint |  | At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2 | 
| Proportion of participants achieving HAI seroconversion |  | At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2 | 
| Proportion of participants with HAI titer >=1:40 |  | At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu, Pandemic influenza, RNA vaccine