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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Grippe; Influenza; Vaccines

Treatments: Biological: Licensed influenza vaccine; Biological: Placebo; Biological: pdmFlu vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06179446

C5561001

Details and patient eligibility

About

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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

• Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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100 participants in 5 patient groups, including a placebo group

pdmFlu vaccine dose A

Experimental group

Treatment:

Biological: pdmFlu vaccine

pdmFlu vaccine dose B

Experimental group

Treatment:

Biological: pdmFlu vaccine

pdmFlu vaccine dose C

Experimental group

Treatment:

Biological: pdmFlu vaccine

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo

Licensed influenza vaccine

Active Comparator group

Treatment:

Biological: Licensed influenza vaccine