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

NCT06179446 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: C5561001NCT06179446
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Grippe; Vaccines; Influenza

Keywords

Flu; Pandemic influenza; RNA vaccine

Outcome Measures

Primary Outcomes (9)

• Percentage of participants by age group reporting local reactions

  For 7 days after vaccination

• Percentage of participants by age group reporting systemic events

  For 7 days after vaccination

• Percentage of participants by age group reporting adverse events

  From vaccination to 4 weeks after each vaccination

• Percentage of participants by age group reporting serious adverse events

  From vaccination to 6 months after last vaccination or through the last visit, whichever is longer

• Percentage of participants by age group reporting medically attended adverse events

  From vaccination to 6 months after last vaccination or through the last visit, whichever is longer

• Percentage of participants by age group with abnormal hematology and chemistry laboratory values

  1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination

• Percentage of participants by age group with grading shifts in hematology and chemistry laboratory assessments

  Between baseline and 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination

• Percentage of participants by age group with new clinically significant ECG abnormalities

  1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination

• Percentage of participants by age group with new troponin I abnormalities

  1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination

Secondary Outcomes (4)

• Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers

  At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination

• Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint

  At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination

• Proportion of participants by age group achieving HAI seroconversion

  At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination

• Proportion of participants by age group with HAI titer >=1:40

  At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination

Study Arms (10)

pdmFlu vaccine 1

EXPERIMENTAL

Biological: pdmFlu vaccine

pdmFlu vaccine 2

EXPERIMENTAL

Biological: pdmFlu vaccine

pdmFlu vaccine 3

EXPERIMENTAL

Biological: pdmFlu vaccine

pdmFlu vaccine 4

EXPERIMENTAL

Biological: pdmFlu vaccine

pdmFlu vaccine 5

EXPERIMENTAL

Biological: pdmFlu vaccine

pdmFlu vaccine 6

EXPERIMENTAL

Biological: pdmFlu vaccine

pdmFlu vaccine 7

EXPERIMENTAL

Biological: pdmFlu vaccine

pdmFlu vaccine 8

EXPERIMENTAL

Biological: pdmFlu vaccine

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Licensed influenza vaccine

ACTIVE COMPARATOR

Biological: Licensed influenza vaccine

Interventions

pdmFlu vaccine BIOLOGICAL

Intramuscular injection

pdmFlu vaccine 1; pdmFlu vaccine 2; pdmFlu vaccine 3; pdmFlu vaccine 4; pdmFlu vaccine 5; pdmFlu vaccine 6; pdmFlu vaccine 7; pdmFlu vaccine 8

Placebo BIOLOGICAL

Intramuscular injection

Placebo

Licensed influenza vaccine BIOLOGICAL

Intramuscular injection

Licensed influenza vaccine

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- Does not meet seasonal influenza vaccine requirements per cohort.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: December 13, 2023
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)