## Protocol Section
### Identification Module
**NCT ID:** NCT06431607

**Brief Title:** A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults

**Official Title:** A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate the Immunogenicity and Safety of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older

#### Organization Study ID Info
**ID:** 222853
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA).

### Conditions Module

**Conditions:**

- Influenza, Human

**Keywords:**

- Influenza

- Safety

- Reactogenicity

- Immunogenicity

- mRNA vaccine

- Healthy younger adults

- Healthy older adults

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** This is an observer blind study.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 1

**Label:** Flu mRNA_YA_Group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 2

**Label:** Flu mRNA_YA_Group 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 3

**Label:** Flu mRNA_YA_Group 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 4

**Label:** Flu mRNA_YA_Group 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly.

**Intervention Names:**

- Combination Product: Active Comparator 1

**Label:** YA_Active Comparator Group 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 6

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 5

**Label:** Flu mRNA_OA_Group 1

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 6

**Label:** Flu mRNA_OA_Group 2

**Type:** EXPERIMENTAL

#### Arm Group 8

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 7

**Label:** Flu mRNA_OA_Group 3

**Type:** EXPERIMENTAL

#### Arm Group 9

**Description:** Eligible participants receive 1 dose of study intervention at Day 1 intramuscularly.

**Intervention Names:**

- Biological: Flu Seasonal mRNA Formulation 8

**Label:** Flu mRNA_OA_Group 4

**Type:** EXPERIMENTAL

#### Arm Group 10

**Description:** Eligible participants receive 1 dose of an active comparator at Day 1 intramuscularly.

**Intervention Names:**

- Combination Product: Active Comparator 2

**Label:** OA_Active Comparator Group 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Flu mRNA_YA_Group 1

**Description:** 1 dose of Flu mRNA Formulation 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.

**Name:** Flu Seasonal mRNA Formulation 1

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Flu mRNA_YA_Group 2

**Description:** 1 dose of Flu mRNA Formulation 2 is administered intramuscularly in the non-dominant upper deltoid to YA at Day 1.

**Name:** Flu Seasonal mRNA Formulation 2

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Flu mRNA_YA_Group 3

**Description:** 1 dose of Flu mRNA Formulation 3 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.

**Name:** Flu Seasonal mRNA Formulation 3

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 4

**Arm Group Labels:**

- Flu mRNA_YA_Group 4

**Description:** 1 dose of Flu mRNA Formulation 4 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.

**Name:** Flu Seasonal mRNA Formulation 4

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 5

**Arm Group Labels:**

- Flu mRNA_OA_Group 1

**Description:** 1 dose of Flu mRNA Formulation 5 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.

**Name:** Flu Seasonal mRNA Formulation 5

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 6

**Arm Group Labels:**

- Flu mRNA_OA_Group 2

**Description:** 1 dose of Flu mRNA Formulation 6 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.

**Name:** Flu Seasonal mRNA Formulation 6

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 7

**Arm Group Labels:**

- Flu mRNA_OA_Group 3

**Description:** 1 dose of Flu mRNA Formulation 7 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.

**Name:** Flu Seasonal mRNA Formulation 7

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 8

**Arm Group Labels:**

- Flu mRNA_OA_Group 4

**Description:** 1 dose of Flu mRNA Formulation 8 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.

**Name:** Flu Seasonal mRNA Formulation 8

**Other Names:**

- GSK4382276A

**Type:** BIOLOGICAL

#### Intervention 9

**Arm Group Labels:**

- YA_Active Comparator Group 1

**Description:** 1 dose of active comparator 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.

**Name:** Active Comparator 1

**Type:** COMBINATION_PRODUCT

#### Intervention 10

**Arm Group Labels:**

- OA_Active Comparator Group 2

**Description:** 1 dose of active comparator 2 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.

**Name:** Active Comparator 2

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Measure:** Geometric mean titer (GMT) of antigen 1 antibody

**Time Frame:** At Day 29

**Measure:** Geometric mean increase (GMI) of Antigen 1 antibody titer

**Time Frame:** From Day 1 to Day 29

**Measure:** Percentage of participants with antigen 1 seroconversion rate (SCR)

**Time Frame:** From Day 1 to Day 29

**Measure:** Percentage of participants with antigen 1 titer greater than or equal to (>=) the cut off value at Day 1

**Time Frame:** At Day 1

**Measure:** Percentage of participants with antigen 1 titer >= the cut off value at Day 29

**Time Frame:** At Day 29

#### Secondary Outcomes

**Measure:** GMT of antigen 2 antibody

**Time Frame:** At Day 29

**Measure:** GMI of antigen 2 antibody titer

**Time Frame:** From Day 1 to Day 29

**Measure:** Percentage of participants with Antigen 2 SCR

**Time Frame:** From Day 1 to Day 29

**Description:** The following administration site events are solicited: pain, redness, swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm).

**Measure:** Percentage of participants reporting each solicited administration site event

**Time Frame:** Day 1 to Day 7

**Description:** The following systemic events are solicited: fever, headache, myalgia, arthralgia, fatigue, chills. Fever is defined as temperature \>=38 °C/100.4°F regardless the location of measurement. The route for measuring temperature is oral.

**Measure:** Percentage of participants reporting each solicited systemic event

**Time Frame:** Day 1 to Day 7

**Description:** An unsolicited AE is defined as an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs.

**Measure:** Percentage of participants reporting unsolicited adverse events (AEs)

**Time Frame:** Day 1 to Day 28

**Description:** An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.

**Measure:** Percentage of participants reporting serious adverse events (SAEs)

**Time Frame:** Day 1 to Day 183

**Description:** The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).

**Measure:** Percentage of participants reporting adverse events of special interest (AESIs)

**Time Frame:** Day 1 to Day 183

**Description:** A MAAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physicians office visits, emergency room visits or hospitalization).

**Measure:** Percentage of participants reporting medically attended adverse events (MAAEs)

**Time Frame:** Day 1 to Day 183

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. A male or female between and including 18 and 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration.
2. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment.
3. Body mass index (BMI) \>=18 Kilograms per meter square (kg/m²) and less than or equal to (\<=) 35kg/m2.
4. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits), independently or with the assistance of a caregiver.
5. Written informed consent obtained from the participant prior to performance of any study-specific procedure.
6. Female participants of non-childbearing potential may be enrolled in the clinical study.
7. Female participants of childbearing potential may be enrolled in the clinical study, if the participant:

   * Has practiced adequate contraception for 1 month prior to the study intervention administration, and
   * Has a negative pregnancy test within 24 hours prior to the study intervention administration, and
   * Has agreed to continue adequate contraception for at least 1 month after study intervention administration.

Exclusion Criteria:

1. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
2. Current or past malignancy, unless completely resolved without sequelae for greater than (\>) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer).
3. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is \>= 200/ cubic millimeter (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than (\<) 50 copies/milliliter \[mL\]) (based on medical records, no laboratory testing required).
4. Participants with a history of, or current suspicion of myocarditis, pericarditis, or idiopathic cardiomyopathy (including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine), or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection will be excluded from the study.
5. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including polyethylene glycol, egg proteins and aminoglycoside antibiotics).
6. Hypersensitivity to latex.
7. Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
8. Any history of dementia or any medical condition that moderately or severely impairs cognition.
9. Any condition that in the judgment of the investigator would make intramuscular injection unsafe.
10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
11. Administration of an influenza vaccine within 180 days before enrollment or planned administration prior to Visit 2 (Day 29) after the study intervention administration.
12. Previous vaccination with a mRNA influenza vaccine.
13. Administration of a vaccine not foreseen by the study protocol in the period starting 30 days (Day -30) before the study intervention administration, or planned administration within 28 days (Visit 2 \[Day 29\]) after the study intervention administration\*.

    * If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified.
14. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
15. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period.
16. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.

    * Up to 3 months prior to the study intervention administration:

    For corticosteroids, this will mean prednisone equivalent \>=20 mg/day. Inhaled, intraarticular and topical steroids are allowed.
    * Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
17. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
18. Pregnant or lactating female participant.
19. Bedridden participants.
20. Female participant planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
21. History of chronic alcohol consumption and/or drug abuse in the past 5 years as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
22. Any study personnel or their immediate dependents, family, or household members.
23. Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** GSKClinicalSupportHD@gsk.com

**Name:** US GSK Clinical Trials Call Center

**Phone:** 877-379-3718

**Role:** CONTACT

**Contact 2:**

**Email:** GSKClinicalSupportHD@gsk.com

**Name:** EU GSK Clinical Trials Call Center

**Phone:** +44 (0) 20 89904466

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hialeah

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Jose Cardona

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Status:** RECRUITING

**Zip:** 33012

**Location 2:**

**City:** Miami

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Kimberly S Cruz

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33147

**Location 3:**

**City:** Miami

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Rafael Ubeda

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Status:** RECRUITING

**Zip:** 33186

**Location 4:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Rupal Trivedi

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Zip:** 60640

**Location 5:**

**City:** Valparaiso

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Robert J. Buynak

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Indiana

**Status:** NOT_YET_RECRUITING

**Zip:** 46383

**Location 6:**

**City:** El Dorado

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Michael Rausch

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Kansas

**Status:** RECRUITING

**Zip:** 67042

**Location 7:**

**City:** Lenexa

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Carlos A Fierro

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Kansas

**Status:** RECRUITING

**Zip:** 66219

**Location 8:**

**City:** Newton

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Troy Holdeman

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Kansas

**Status:** RECRUITING

**Zip:** 67114

**Location 9:**

**City:** Wichita

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Terry D Klein

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Kansas

**Status:** RECRUITING

**Zip:** 67207

**Location 10:**

**City:** Lexington

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Mark S Adams

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Kentucky

**Status:** RECRUITING

**Zip:** 40509

**Location 11:**

**City:** Rochester

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Patrick Connors

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** New York

**Status:** RECRUITING

**Zip:** 14609

**Location 12:**

**City:** Greensboro

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Alexander Vance Murray

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27408

**Location 13:**

**City:** East Greenwich

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** David L Fried

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Rhode Island

**Status:** NOT_YET_RECRUITING

**Zip:** 02818

**Location 14:**

**City:** Knoxville

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** William Smith

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Tennessee

**Status:** RECRUITING

**Zip:** 37909

**Location 15:**

**City:** Austin

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Laurence Chu

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Texas

**Status:** NOT_YET_RECRUITING

**Zip:** 78705

**Location 16:**

**City:** Fort Worth

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** William M Seger

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Texas

**Status:** RECRUITING

**Zip:** 76135

**Location 17:**

**City:** Tomball

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Vicki Miller

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Texas

**Status:** RECRUITING

**Zip:** 77375

**Location 18:**

**City:** Newport News

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** George H Freeman

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Virginia

**Status:** RECRUITING

**Zip:** 23606

**Location 19:**

**City:** Norfolk

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Mary Bailey

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Virginia

**Status:** NOT_YET_RECRUITING

**Zip:** 23502

### IPD Sharing Statement Module

**Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

**Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

**URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/

## 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 - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
