modRNA Vaccine for Flu
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor to understand any specific requirements.
What data supports the effectiveness of the modRNA Vaccine for Flu treatment?
Research shows that quadrivalent influenza vaccines (QIVs), which are part of the treatment, are effective because they include two A strains and two B lineages, reducing the chance of a mismatch with circulating flu strains. This makes them more effective than trivalent vaccines, which only cover one B lineage.12345
Is the modRNA Vaccine for Flu safe for humans?
The quadrivalent influenza vaccines (QIVs) have been studied for safety in various age groups, showing a low rate of adverse events (side effects), with most not requiring medical attention. In a study with 2013 participants, only 9.09% reported any side effects, and none required hospitalization, indicating a generally safe profile.12367
How is the modRNA Vaccine for Flu different from other flu treatments?
The modRNA Vaccine for Flu is unique because it uses messenger RNA (mRNA) technology, which allows for rapid development and the potential to create a universal flu vaccine that provides long-lasting protection against multiple strains of the virus. This is different from traditional flu vaccines that typically use inactivated or live attenuated viruses.13589
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for healthy adults aged 18 to 49 who can commit to the study's schedule and procedures. They must not have received any flu vaccine in the past 6 months and should be able to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single shot of either the pdmFlu vaccine, a licensed influenza vaccine, or a placebo
Follow-up
Participants are monitored for safety and effectiveness after receiving the vaccine
Treatment Details
Interventions
- PF-07985819 pdmFlu Vaccine
- Placebo
- Quadrivalent influenza vaccine (QIV)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University