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OpenTrials
Completed

NCT Number: NCT06179446

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

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.

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Key information

Conditions

Grippe Infections Influenza Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccines Virus Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pdmFlu vaccine

Biological

Intramuscular injection

Placebo

Biological

Intramuscular injection

Licensed influenza vaccine

Biological

Intramuscular injection

Primary outcomes

  1. Percentage of participants by age group reporting local reactions

    Time frame: For 7 days after vaccination

  2. Percentage of participants by age group reporting systemic events

    Time frame: For 7 days after vaccination

  3. Percentage of participants by age group reporting adverse events

    Time frame: From vaccination to 4 weeks after each vaccination

  4. Percentage of participants by age group reporting serious adverse events

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

  5. Percentage of participants by age group reporting medically attended adverse events

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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  9. Percentage of participants by age group with new troponin I abnormalities

    Time frame: 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

  1. Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers

    Time frame: 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

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

    Time frame: 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

  3. Proportion of participants by age group achieving HAI seroconversion

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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 ADULTS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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