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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

NCT ID: NCT06179446

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2025-09-23

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 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.

Detailed Description

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Conditions

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Grippe Influenza Vaccines

Keywords

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Flu Pandemic influenza RNA vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pdmFlu vaccine 1

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 2

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 3

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 4

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 5

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 6

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 7

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 8

Group Type EXPERIMENTAL

pdmFlu vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Licensed influenza vaccine

Group Type ACTIVE_COMPARATOR

Licensed influenza vaccine

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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pdmFlu vaccine

Intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Intramuscular injection

Intervention Type BIOLOGICAL

Licensed influenza vaccine

Intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Exclusion Criteria

\- Does not meet seasonal influenza vaccine requirements per cohort.
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, United States

Site Status

Research Centers of America

Hollywood, Florida, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C5561001

To obtain contact information for a study center near you, click here.

Other Identifiers

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NCT06179446

Identifier Type: REGISTRY

Identifier Source: secondary_id

C5561001

Identifier Type: -

Identifier Source: org_study_id