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Clinical trial

A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS

ID
Name
C4781013
Description
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.
Trial arms
Trial start
2024-05-24
Estimated PCD
2025-02-05
Trial end
2025-02-05
Status
Recruiting
Phase
Early phase I
Treatment
Influenza ModRNA Vaccine
Intramuscular injection
Arms:
SSA: Influenza ModRNA Vaccine 2A, SSA: Influenza ModRNA Vaccine 3A, SSA: Influenza ModRNA Vaccine 4A, SSA: Influenza ModRNA Vaccine 5A, SSB: Influenza ModRNA Vaccine 3B, SSB: Influenza ModRNA Vaccine 4B, SSB: Influenza ModRNA Vaccine 5B, SSC: Influenza ModRNA Vaccine 3C, SSC: Influenza ModRNA Vaccine 4C, SSC: Influenza ModRNA Vaccine 5C, SSC: Influenza ModRNA Vaccine 6C, SSC: Influenza ModRNA Vaccine 7C, SSC: Influenza ModRNA Vaccine 8C, SSC: Influenza ModRNA Vaccine 9C
Quadrivalent Influenza Vaccine (QIV)
Intramuscular injection
Arms:
SSA: QIV1, SSB: QIV2, SSB: QIV3, SSC: QIV2, SSC: QIV3
Size
1170
Primary endpoint
SSA - Percentage of Participants Reporting Local Reactions After Vaccination
From Day 1 Through at least Day 7 After Vaccination
SSA - Percentage of Participants Reporting Systemic Events After Vaccination
From Day 1 Through at least Day 7 After Vaccination
SSA - Percentage of Participants Reporting Adverse Events After Vaccination
From Day 1 Through 4 Weeks After Vaccination
SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)
From Day 1 Through 6 Months After Vaccination
SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
From Day 1 Through 6 Months After Vaccination
SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)
From Day 1 Through 6 Months After Vaccination
SSB - Percentage of Participants Reporting Local Reactions After Vaccination
From Day 1 Through at least Day 7 After Vaccination
SSB - Percentage of Participants Reporting Systemic Events After Vaccination
From Day 1 Through at least Day 7 After Vaccination
SSB - Percentage of Participants Reporting Adverse Events After Vaccination
From Day 1 Through 4 Weeks After Vaccination
SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)
From Day 1 Through 6 Months After Vaccination
SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
From Day 1 Through 6 Months After Vaccination
SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)
From Day 1 Through 6 Months After Vaccination
SSC - Percentage of Participants Reporting Local Reactions After Vaccination
From Day 1 Through at least Day 7 After Vaccination
SSC - Percentage of Participants Reporting Systemic Events After Vaccination
From Day 1 Through at least Day 7 After Vaccination
SSC - Percentage of Participants Reporting Adverse Events After Vaccination
From Day 1 Through 4 Weeks After Vaccination
SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)
From Day 1 Through 6 Months After Vaccination
SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
From Day 1 Through 6 Months After Vaccination
SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)
From Day 1 Through 6 Months After Vaccination
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'This study will be an observer-blinded and Sponsor-unblinded study.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1170, 'type': 'ESTIMATED'}}
Updated at
2024-05-31

1 organization

2 products

2 indications

Organization
Pfizer
Product
Influenza ModRNA Vaccine
Indication
Influenza
Indication
Human
Product
Quadrivalent Influenza Vaccine