Rochester Clinical Research | Rochester, NY
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:
- safe; and
- how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.
RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.
Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.
The study is seeking for participants who:
- are at least 18 years of age
- have not received an influenza vaccine within the last 6 months
- are generally healthy
This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).
All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:
- 1 of the modRNA influenza vaccines that is being studied; or
- an approved influenza vaccine approved for use in their respective age group.
Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria
Applies to all 3 substudies:
- participants ≥18 years of age.
- generally healthy participants.
Substudy C ONLY:
- receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.
Key Exclusion Criteria
All 3 substudies:
- diagnosis of influenza (by clinical testing) in the last 6 months.
- immunocompromised individuals with known or suspected immunodeficiency
- receipt of any investigational or licensed influenza vaccines within 6 months.
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,202 participants in 19 patient groups
Trial contacts and locations
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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