Influenza, Human Clinical Trial
Official title:
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
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.
| Status | Recruiting |
| Enrollment | 1170 |
| Est. completion date | February 5, 2025 |
| Est. primary completion date | February 5, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Anaheim Clinical Trials, LLC | Anaheim | California |
| United States | Headlands Horizons LLC | Brownsville | Texas |
| United States | Charlottesville Medical Research | Charlottesville | Virginia |
| United States | Clinical Research Professionals | Chesterfield | Missouri |
| United States | Duke Vaccine and Trials Unit | Durham | North Carolina |
| United States | Indago Research & Health Center, Inc | Hialeah | Florida |
| United States | Research Centers of America | Hollywood | Florida |
| United States | Research Centers of America ( Hollywood ) | Hollywood | Florida |
| United States | East-West Medical Research Institute | Honolulu | Hawaii |
| United States | Alliance for Multispecialty Research, LLC | Kansas City | Missouri |
| United States | Orange County Research Center | Lake Forest | California |
| United States | SMS Clinical Research | Mesquite | Texas |
| United States | Palm Springs Community Health Center | Miami Lakes | Florida |
| United States | Clinical Research Consulting | Milford | Connecticut |
| United States | Alliance for Multispecialty Research, LLC | New Orleans | Louisiana |
| United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
| United States | Headlands Research Orlando | Orlando | Florida |
| United States | DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania |
| United States | M3 Wake Research, Inc. | Raleigh | North Carolina |
| United States | Rochester Clinical Research, LLC | Rochester | New York |
| United States | Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota |
| United States | J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah |
| United States | J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah |
| United States | Clinical Trials of Texas, LLC | San Antonio | Texas |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | Headlands Research - Scottsdale | Scottsdale | Arizona |
| United States | Qps-Mra, Llc | South Miami | Florida |
| United States | Dynamed Clinical Research, LP d/b/a DM Clinical Research | Tomball | Texas |
| United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SSA - Percentage of Participants Reporting Local Reactions After Vaccination | Pain at the injection site, redness, and swelling. | From Day 1 Through at least Day 7 After Vaccination | |
| Primary | SSA - Percentage of Participants Reporting Systemic Events After Vaccination | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain. | From Day 1 Through at least Day 7 After Vaccination | |
| Primary | SSA - Percentage of Participants Reporting Adverse Events After Vaccination | As elicited by investigational site staff | From Day 1 Through 4 Weeks After Vaccination | |
| Primary | SSA - Percentage of Participants Reporting Serious Adverse Events (SAE) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSB - Percentage of Participants Reporting Local Reactions After Vaccination | Pain at injection site, redness, and swelling. | From Day 1 Through at least Day 7 After Vaccination | |
| Primary | SSB - Percentage of Participants Reporting Systemic Events After Vaccination | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain. | From Day 1 Through at least Day 7 After Vaccination | |
| Primary | SSB - Percentage of Participants Reporting Adverse Events After Vaccination | As elicited by investigational site staff | From Day 1 Through 4 Weeks After Vaccination | |
| Primary | SSB - Percentage of Participants Reporting Serious Adverse Events (SAE) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSC - Percentage of Participants Reporting Local Reactions After Vaccination | Pain at the injection site, redness, and swelling. | From Day 1 Through at least Day 7 After Vaccination | |
| Primary | SSC - Percentage of Participants Reporting Systemic Events After Vaccination | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain. | From Day 1 Through at least Day 7 After Vaccination | |
| Primary | SSC - Percentage of Participants Reporting Adverse Events After Vaccination | As elicited by investigational site staff | From Day 1 Through 4 Weeks After Vaccination | |
| Primary | SSC - Percentage of Participants Reporting Serious Adverse Events (SAE) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Primary | SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs) | As elicited by investigational site staff | From Day 1 Through 6 Months After Vaccination | |
| Secondary | SSA - HAI Geometric Mean Titers (GMTs) for each strain | As measured at the central laboratory | 4 Weeks After Vaccination | |
| Secondary | SSA - HAI geometric mean fold rise (GMFR) for each strain | As measured at the central laboratory | 4 Weeks After Vaccination | |
| Secondary | SSA - The proportion of participants achieving HAI seroconversion for each strain | As measured at the central laboratory | 4 Weeks After Vaccination | |
| Secondary | SSA - The proportion of participants with HAI titers =1:40 for each strain | As measured at the central laboratory | Baseline and 4 Weeks After Vaccination | |
| Secondary | SSB - HAI geometric mean titers (GMTs) for each strain | As measured at the central laboratory | 4 Weeks After Vaccination | |
| Secondary | SSB - HAI geometric mean fold rise (GMFR) for each strain | As measured at the central laboratory | 4 Weeks After Vaccination | |
| Secondary | SSB - The proportion of participants achieving HAI seroconversion for each strain | As measured at the central laboratory | 4 Weeks After Vaccination | |
| Secondary | SSB - The proportion of participants with HAI titers =1:40 for each strain | As measured at the central laboratory | Baseline and 4 Weeks After Vaccination |
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