## Protocol Section
### Identification Module
**NCT ID:** NCT06436703

**Brief Title:** 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

#### Organization Study ID Info
**ID:** C4781013
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2025-02-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Influenza, Human

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** This study will be an observer-blinded and Sponsor-unblinded study.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1170

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSA: Influenza ModRNA Vaccine 2A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSA: Influenza ModRNA Vaccine 3A

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSA: Influenza ModRNA Vaccine 4A

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** - Single dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSA: Influenza ModRNA Vaccine 5A

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** - Single dose on Day 1

**Intervention Names:**

- Biological: Quadrivalent Influenza Vaccine (QIV)

**Label:** SSA: QIV1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 6

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSB: Influenza ModRNA Vaccine 3B

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSB: Influenza ModRNA Vaccine 4B

**Type:** EXPERIMENTAL

#### Arm Group 8

**Description:** - Single dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSB: Influenza ModRNA Vaccine 5B

**Type:** EXPERIMENTAL

#### Arm Group 9

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Quadrivalent Influenza Vaccine (QIV)

**Label:** SSB: QIV2

**Type:** ACTIVE_COMPARATOR

#### Arm Group 10

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Quadrivalent Influenza Vaccine (QIV)

**Label:** SSB: QIV3

**Type:** ACTIVE_COMPARATOR

#### Arm Group 11

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSC: Influenza ModRNA Vaccine 3C

**Type:** EXPERIMENTAL

#### Arm Group 12

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSC: Influenza ModRNA Vaccine 4C

**Type:** EXPERIMENTAL

#### Arm Group 13

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSC: Influenza ModRNA Vaccine 5C

**Type:** EXPERIMENTAL

#### Arm Group 14

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSC: Influenza ModRNA Vaccine 6C

**Type:** EXPERIMENTAL

#### Arm Group 15

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSC: Influenza ModRNA Vaccine 7C

**Type:** EXPERIMENTAL

#### Arm Group 16

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSC: Influenza ModRNA Vaccine 8C

**Type:** EXPERIMENTAL

#### Arm Group 17

**Description:** - Single dose on Day 1

**Intervention Names:**

- Biological: Influenza ModRNA Vaccine

**Label:** SSC: Influenza ModRNA Vaccine 9C

**Type:** EXPERIMENTAL

#### Arm Group 18

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Quadrivalent Influenza Vaccine (QIV)

**Label:** SSC: QIV2

**Type:** ACTIVE_COMPARATOR

#### Arm Group 19

**Description:** - Single Dose on Day 1

**Intervention Names:**

- Biological: Quadrivalent Influenza Vaccine (QIV)

**Label:** SSC: QIV3

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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

**Description:** Intramuscular injection

**Name:** Influenza ModRNA Vaccine

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- SSA: QIV1

- SSB: QIV2

- SSB: QIV3

- SSC: QIV2

- SSC: QIV3

**Description:** Intramuscular injection

**Name:** Quadrivalent Influenza Vaccine (QIV)

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Pain at the injection site, redness, and swelling.

**Measure:** SSA - Percentage of Participants Reporting Local Reactions After Vaccination

**Time Frame:** From Day 1 Through at least Day 7 After Vaccination

**Description:** Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.

**Measure:** SSA - Percentage of Participants Reporting Systemic Events After Vaccination

**Time Frame:** From Day 1 Through at least Day 7 After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSA - Percentage of Participants Reporting Adverse Events After Vaccination

**Time Frame:** From Day 1 Through 4 Weeks After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** Pain at injection site, redness, and swelling.

**Measure:** SSB - Percentage of Participants Reporting Local Reactions After Vaccination

**Time Frame:** From Day 1 Through at least Day 7 After Vaccination

**Description:** Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.

**Measure:** SSB - Percentage of Participants Reporting Systemic Events After Vaccination

**Time Frame:** From Day 1 Through at least Day 7 After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSB - Percentage of Participants Reporting Adverse Events After Vaccination

**Time Frame:** From Day 1 Through 4 Weeks After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** Pain at the injection site, redness, and swelling.

**Measure:** SSC - Percentage of Participants Reporting Local Reactions After Vaccination

**Time Frame:** From Day 1 Through at least Day 7 After Vaccination

**Description:** Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.

**Measure:** SSC - Percentage of Participants Reporting Systemic Events After Vaccination

**Time Frame:** From Day 1 Through at least Day 7 After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSC - Percentage of Participants Reporting Adverse Events After Vaccination

**Time Frame:** From Day 1 Through 4 Weeks After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

**Description:** As elicited by investigational site staff

**Measure:** SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)

**Time Frame:** From Day 1 Through 6 Months After Vaccination

#### Secondary Outcomes

**Description:** As measured at the central laboratory

**Measure:** SSA - HAI Geometric Mean Titers (GMTs) for each strain

**Time Frame:** 4 Weeks After Vaccination

**Description:** As measured at the central laboratory

**Measure:** SSA - HAI geometric mean fold rise (GMFR) for each strain

**Time Frame:** 4 Weeks After Vaccination

**Description:** As measured at the central laboratory

**Measure:** SSA - The proportion of participants achieving HAI seroconversion for each strain

**Time Frame:** 4 Weeks After Vaccination

**Description:** As measured at the central laboratory

**Measure:** SSA - The proportion of participants with HAI titers ≥1:40 for each strain

**Time Frame:** Baseline and 4 Weeks After Vaccination

**Description:** As measured at the central laboratory

**Measure:** SSB - HAI geometric mean titers (GMTs) for each strain

**Time Frame:** 4 Weeks After Vaccination

**Description:** As measured at the central laboratory

**Measure:** SSB - HAI geometric mean fold rise (GMFR) for each strain

**Time Frame:** 4 Weeks After Vaccination

**Description:** As measured at the central laboratory

**Measure:** SSB - The proportion of participants achieving HAI seroconversion for each strain

**Time Frame:** 4 Weeks After Vaccination

**Description:** As measured at the central laboratory

**Measure:** SSB - The proportion of participants with HAI titers ≥1:40 for each strain

**Time Frame:** Baseline and 4 Weeks After Vaccination

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ClinicalTrials.gov_Inquiries@pfizer.com

**Name:** Pfizer CT.gov Call Center

**Phone:** 1-800-718-1021

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Scottsdale

**Country:** United States

**Facility:** Headlands Research - Scottsdale

**State:** Arizona

**Status:** NOT_YET_RECRUITING

**Zip:** 85260

**Location 2:**

**City:** Anaheim

**Country:** United States

**Facility:** Anaheim Clinical Trials, LLC

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 92801

**Location 3:**

**City:** Lake Forest

**Country:** United States

**Facility:** Orange County Research Center

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 92630

**Location 4:**

**City:** San Diego

**Country:** United States

**Facility:** Artemis Institute for Clinical Research

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 92103

**Location 5:**

**City:** Walnut Creek

**Country:** United States

**Facility:** Diablo Clinical Research, Inc.

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 94598

**Location 6:**

**City:** Milford

**Country:** United States

**Facility:** Clinical Research Consulting

**State:** Connecticut

**Status:** NOT_YET_RECRUITING

**Zip:** 06460

**Location 7:**

**City:** Hialeah

**Country:** United States

**Facility:** Indago Research & Health Center, Inc

**State:** Florida

**Status:** RECRUITING

**Zip:** 33012

**Location 8:**

**City:** Hollywood

**Country:** United States

**Facility:** Research Centers of America ( Hollywood )

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33024

**Location 9:**

**City:** Hollywood

**Country:** United States

**Facility:** Research Centers of America

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33024

**Location 10:**

**City:** Miami Lakes

**Country:** United States

**Facility:** Palm Springs Community Health Center

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33014

**Location 11:**

**City:** Orlando

**Country:** United States

**Facility:** Clinical Neuroscience Solutions, Inc.

**State:** Florida

**Status:** RECRUITING

**Zip:** 32801

**Location 12:**

**City:** Orlando

**Country:** United States

**Facility:** Headlands Research Orlando

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 32819

**Location 13:**

**City:** South Miami

**Country:** United States

**Facility:** Qps-Mra, Llc

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33143

**Location 14:**

**City:** Honolulu

**Country:** United States

**Facility:** East-West Medical Research Institute

**State:** Hawaii

**Status:** NOT_YET_RECRUITING

**Zip:** 96814

**Location 15:**

**City:** New Orleans

**Country:** United States

**Facility:** Alliance for Multispecialty Research, LLC

**State:** Louisiana

**Status:** NOT_YET_RECRUITING

**Zip:** 70119

**Location 16:**

**City:** Saint Paul

**Country:** United States

**Facility:** Prism Research LLC dba Nucleus Network

**State:** Minnesota

**Status:** NOT_YET_RECRUITING

**Zip:** 55114

**Location 17:**

**City:** Chesterfield

**Country:** United States

**Facility:** Clinical Research Professionals

**State:** Missouri

**Status:** NOT_YET_RECRUITING

**Zip:** 63005

**Location 18:**

**City:** Kansas City

**Country:** United States

**Facility:** Alliance for Multispecialty Research, LLC

**State:** Missouri

**Status:** NOT_YET_RECRUITING

**Zip:** 64114

**Location 19:**

**City:** Rochester

**Country:** United States

**Facility:** Rochester Clinical Research, LLC

**State:** New York

**Status:** NOT_YET_RECRUITING

**Zip:** 14609

**Location 20:**

**City:** Durham

**Country:** United States

**Facility:** Duke Vaccine and Trials Unit

**State:** North Carolina

**Status:** NOT_YET_RECRUITING

**Zip:** 27703

**Location 21:**

**City:** Raleigh

**Country:** United States

**Facility:** M3 Wake Research, Inc.

**State:** North Carolina

**Status:** NOT_YET_RECRUITING

**Zip:** 27612

**Location 22:**

**City:** Philadelphia

**Country:** United States

**Facility:** DM Clinical Research - Philadelphia

**State:** Pennsylvania

**Status:** NOT_YET_RECRUITING

**Zip:** 19107

**Location 23:**

**City:** Brownsville

**Country:** United States

**Facility:** Headlands Horizons LLC

**State:** Texas

**Status:** NOT_YET_RECRUITING

**Zip:** 78526

**Location 24:**

**City:** Mesquite

**Country:** United States

**Facility:** SMS Clinical Research

**State:** Texas

**Status:** NOT_YET_RECRUITING

**Zip:** 75149

**Location 25:**

**City:** San Antonio

**Country:** United States

**Facility:** Clinical Trials of Texas, LLC

**State:** Texas

**Status:** NOT_YET_RECRUITING

**Zip:** 78229

**Location 26:**

**City:** Tomball

**Country:** United States

**Facility:** Dynamed Clinical Research, LP d/b/a DM Clinical Research

**State:** Texas

**Status:** NOT_YET_RECRUITING

**Zip:** 77375

**Location 27:**

**City:** Salt Lake City

**Country:** United States

**Facility:** J. Lewis Research, Inc. / Foothill Family Clinic

**State:** Utah

**Status:** RECRUITING

**Zip:** 84109

**Location 28:**

**City:** Salt Lake City

**Country:** United States

**Facility:** J. Lewis Research, Inc. / Foothill Family Clinic South

**State:** Utah

**Status:** RECRUITING

**Zip:** 84121

**Location 29:**

**City:** Charlottesville

**Country:** United States

**Facility:** Charlottesville Medical Research

**State:** Virginia

**Status:** RECRUITING

**Zip:** 22911

#### Overall Officials

**Official 1:**

**Affiliation:** Pfizer

**Name:** Pfizer CT.gov Call Center

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

**IPD Sharing:** YES

**URL:** https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

### References Module

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here.

**URL:** https://pmiform.com/clinical-trial-info-request?StudyID=C4781013

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009976

- Term: Orthomyxoviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: HIGH

- As Found: Influenza

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12902

- Name: Orthomyxoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007251

- Term: Influenza, Human

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: HIGH

- As Found: Other

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014612

- Term: Vaccines

### Misc Info Module

- Version Holder: 2024-05-31
