PF-07852352 Influenza saRNA 1
BiologicalIntramuscular injection
NCT Number: NCT05227001
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who:
* Are between the age of 18 to 49 years old. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Are healthy as determined by medical history, physical examinations, and the study doctor. * For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children. * Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.
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Notify Me18 year–49 year
All sexes
Interventional
Phase 1
Arizona Heart Rhythm Center, Phoenix, Arizona, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Time frame: For 10 days after vaccination
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
Time frame: For 10 days after vaccination
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.
Time frame: From vaccination to 4 weeks after vaccination
As elicited by investigational site staff.
Time frame: From vaccination to 6 months after vaccination
As elicited by investigational site staff.
Time frame: 2 days after vaccination
As measured at the central laboratory
Time frame: 1 week after vaccination
As measured at the central laboratory
Time frame: Between baseline and 2 days after vaccination
As measured at the central laboratory.
Time frame: Between baseline and 1 week after vaccination
As measured at the central laboratory
Time frame: 2 days after vaccination
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
Time frame: 1 week after vaccination
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
Time frame: At Baseline, and 1-, 2- and 4-weeks after vaccination
As measured at the central laboratory
Time frame: At Baseline, and 1-, 2- and 4-weeks after vaccination
As measured at the central laboratory
Time frame: At 1-, 2-, and 4-weeks after vaccination
As measured at the central laboratory
Time frame: At Baseline, and 1-, 2-, and 4-weeks after vaccination
As measured at the central laboratory
Pfizer
Industry
A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SELF-AMPLIFYING RNA VACCINE PREPARATIONS AGAINST INFLUENZA IN HEALTHY INDIVIDUALS
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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