A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza
- Conditions
- GrippeInfluenzaVaccines
- Interventions
- Biological: pdmFlu vaccineBiological: PlaceboBiological: Licensed influenza vaccine
- Registration Number
- NCT06179446
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 157
- 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
- Does not meet seasonal influenza vaccine requirements per cohort.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description pdmFlu vaccine 1 pdmFlu vaccine - pdmFlu vaccine 2 pdmFlu vaccine - pdmFlu vaccine 3 pdmFlu vaccine - pdmFlu vaccine 4 pdmFlu vaccine - pdmFlu vaccine 5 pdmFlu vaccine - pdmFlu vaccine 6 pdmFlu vaccine - Placebo Placebo - Licensed influenza vaccine Licensed influenza vaccine - pdmFlu vaccine 7 pdmFlu vaccine - pdmFlu vaccine 8 pdmFlu vaccine -
- Primary Outcome Measures
Name Time Method Percentage of participants by age group reporting local reactions 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 systemic events For 7 days after 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 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Pfizer Clinical Research Unit - New Haven
🇺🇸New Haven, Connecticut, United States
Research Centers of America ( Hollywood )
🇺🇸Hollywood, Florida, United States
NYU Langone Health
🇺🇸New York, New York, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States