A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
- Conditions
- Influenza, Human
- Interventions
- Biological: Influenza ModRNA VaccineBiological: Quadrivalent Influenza Vaccine (QIV)
- Registration Number
- NCT06436703
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1202
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSA: Influenza ModRNA Vaccine 4A Influenza ModRNA Vaccine - Single Dose on Day 1 SSA: Influenza ModRNA Vaccine 2A Influenza ModRNA Vaccine - Single Dose on Day 1 SSB: Influenza ModRNA Vaccine 4B Influenza ModRNA Vaccine - Single Dose on Day 1 SSB: QIV2 Quadrivalent Influenza Vaccine (QIV) - Single Dose on Day 1 SSA: Influenza ModRNA Vaccine 3A Influenza ModRNA Vaccine - Single Dose on Day 1 SSA: Influenza ModRNA Vaccine 5A Influenza ModRNA Vaccine - Single dose on Day 1 SSA: QIV1 Quadrivalent Influenza Vaccine (QIV) - Single dose on Day 1 SSB: Influenza ModRNA Vaccine 3B Influenza ModRNA Vaccine - Single Dose on Day 1 SSB: Influenza ModRNA Vaccine 5B Influenza ModRNA Vaccine - Single dose on Day 1 SSB: QIV3 Quadrivalent Influenza Vaccine (QIV) - Single Dose on Day 1 SSC: Influenza ModRNA Vaccine 5C Influenza ModRNA Vaccine - Single Dose on Day 1 SSC: Influenza ModRNA Vaccine 7C Influenza ModRNA Vaccine - Single Dose on Day 1 SSC: QIV2 Quadrivalent Influenza Vaccine (QIV) - Single Dose on Day 1 SSC: Influenza ModRNA Vaccine 3C Influenza ModRNA Vaccine - Single Dose on Day 1 SSC: Influenza ModRNA Vaccine 4C Influenza ModRNA Vaccine - Single Dose on Day 1 SSC: Influenza ModRNA Vaccine 9C Influenza ModRNA Vaccine - Single dose on Day 1 SSC: Influenza ModRNA Vaccine 6C Influenza ModRNA Vaccine - Single Dose on Day 1 SSC: QIV3 Quadrivalent Influenza Vaccine (QIV) - Single Dose on Day 1 SSC: Influenza ModRNA Vaccine 8C Influenza ModRNA Vaccine - Single Dose on Day 1
- Primary Outcome Measures
Name Time Method SSA - Percentage of Participants Reporting Serious Adverse Events (SAE) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSB - Percentage of Participants Reporting Local Reactions After Vaccination From Day 1 Through at least Day 7 After Vaccination Pain at injection site, redness, and swelling.
SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSC - Percentage of Participants Reporting Systemic Events After Vaccination From Day 1 Through at least Day 7 After Vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
SSB - Percentage of Participants Reporting Serious Adverse Events (SAE) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSC - Percentage of Participants Reporting Adverse Events After Vaccination From Day 1 Through 4 Weeks After Vaccination As elicited by investigational site staff
SSC - Percentage of Participants Reporting Serious Adverse Events (SAE) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSA - Percentage of Participants Reporting Local Reactions After Vaccination From Day 1 Through at least Day 7 After Vaccination Pain at the injection site, redness, and swelling.
SSA - Percentage of Participants Reporting Systemic Events After Vaccination From Day 1 Through at least Day 7 After Vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
SSA - Percentage of Participants Reporting Adverse Events After Vaccination From Day 1 Through 4 Weeks After Vaccination As elicited by investigational site staff
SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSB - Percentage of Participants Reporting Adverse Events After Vaccination From Day 1 Through 4 Weeks After Vaccination As elicited by investigational site staff
SSB - Percentage of Participants Reporting Systemic Events After Vaccination From Day 1 Through at least Day 7 After Vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs) From Day 1 Through 6 Months After Vaccination As elicited by investigational site staff
SSC - Percentage of Participants Reporting Local Reactions After Vaccination From Day 1 Through at least Day 7 After Vaccination Pain at the injection site, redness, and swelling.
- Secondary Outcome Measures
Name Time Method SSA - The proportion of participants with HAI titers ≥1:40 for each strain Baseline and 4 Weeks After Vaccination As measured at the central laboratory
SSA - The proportion of participants achieving HAI seroconversion for each strain 4 Weeks After Vaccination As measured at the central laboratory
SSB - The proportion of participants achieving HAI seroconversion for each strain 4 Weeks After Vaccination As measured at the central laboratory
SSB - HAI geometric mean titers (GMTs) for each strain 4 Weeks After Vaccination As measured at the central laboratory
SSB - The proportion of participants with HAI titers ≥1:40 for each strain Baseline and 4 Weeks After Vaccination As measured at the central laboratory
SSB - HAI geometric mean fold rise (GMFR) for each strain 4 Weeks After Vaccination As measured at the central laboratory
SSA - HAI Geometric Mean Titers (GMTs) for each strain 4 Weeks After Vaccination As measured at the central laboratory
SSA - HAI geometric mean fold rise (GMFR) for each strain 4 Weeks After Vaccination As measured at the central laboratory
Trial Locations
- Locations (29)
Alliance for Multispecialty Research, LLC
🇺🇸Norfolk, Virginia, United States
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Orange County Research Center
🇺🇸Lake Forest, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Research Centers of America ( Hollywood )
🇺🇸Hollywood, Florida, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Scroll for more (19 remaining)Alliance for Multispecialty Research, LLC🇺🇸Norfolk, Virginia, United States