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

NCT06179446

CompletedPhase 1

Sponsor: Pfizer

Conditions: Grippe, Influenza, Vaccines

Interventions: pdmFlu vaccine, Placebo, Licensed influenza vaccine

Countries: United States

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 ages of 18 to 49 years old or 65 to 84 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 * 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. 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 13 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.

Eligibility overview

Sex: ALL

Age: 18 Years to 84 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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 cohort.
Locations (3)
  • New Haven, Connecticut, United States
  • Hollywood, Florida, United States
  • New York, New York, United States