Clinical trial NCT06436703: A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
Official title: A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza, Human
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 1202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: SSA - Percentage of Participants Reporting Local Reactions After Vaccination
timeFrame: From Day 1 Through at least Day 7 After Vaccination
measure: SSA - Percentage of Participants Reporting Systemic Events After Vaccination
timeFrame: From Day 1 Through at least Day 7 After Vaccination
measure: SSA - Percentage of Participants Reporting Adverse Events After Vaccination
timeFrame: From Day 1 Through 4 Weeks After Vaccination
measure: SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSB - Percentage of Participants Reporting Local Reactions After Vaccination
timeFrame: From Day 1 Through at least Day 7 After Vaccination
measure: SSB - Percentage of Participants Reporting Systemic Events After Vaccination
timeFrame: From Day 1 Through at least Day 7 After Vaccination
measure: SSB - Percentage of Participants Reporting Adverse Events After Vaccination
timeFrame: From Day 1 Through 4 Weeks After Vaccination
measure: SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSC - Percentage of Participants Reporting Local Reactions After Vaccination
timeFrame: From Day 1 Through at least Day 7 After Vaccination
measure: SSC - Percentage of Participants Reporting Systemic Events After Vaccination
timeFrame: From Day 1 Through at least Day 7 After Vaccination
measure: SSC - Percentage of Participants Reporting Adverse Events After Vaccination
timeFrame: From Day 1 Through 4 Weeks After Vaccination
measure: SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
timeFrame: From Day 1 Through 6 Months After Vaccination
measure: SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)
timeFrame: From Day 1 Through 6 Months After Vaccination
Secondary outcomes:
measure: SSA - HAI Geometric Mean Titers (GMTs) for each strain
timeFrame: 4 Weeks After Vaccination
measure: SSA - HAI geometric mean fold rise (GMFR) for each strain
timeFrame: 4 Weeks After Vaccination
measure: SSA - The proportion of participants achieving HAI seroconversion for each strain
timeFrame: 4 Weeks After Vaccination
measure: SSA - The proportion of participants with HAI titers ≥1:40 for each strain
timeFrame: Baseline and 4 Weeks After Vaccination
measure: SSB - HAI geometric mean titers (GMTs) for each strain
timeFrame: 4 Weeks After Vaccination
measure: SSB - HAI geometric mean fold rise (GMFR) for each strain
timeFrame: 4 Weeks After Vaccination
measure: SSB - The proportion of participants achieving HAI seroconversion for each strain
timeFrame: 4 Weeks After Vaccination
measure: SSB - The proportion of participants with HAI titers ≥1:40 for each strain
timeFrame: Baseline and 4 Weeks After Vaccination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: New Orleans
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Louisiana
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Durham
country: United States
facility: Duke Vaccine and Trials Unit
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Brownsville
country: United States
facility: Headlands Horizons LLC
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC dba Flourish Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: