A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults

The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: F2C22C/DL001Z; Biological: F2B22A/DL001Z; Biological: F2B22B/DL001Z; Biological: F2B22C/DL001Z; Biological: F2B22D/DL001Z; Biological: F2B22E/DL001Z; Biological: F2F22A/DL001Z; Biological: F2F22B/DL001Z; Biological: F2F22C/DL001Z; Biological: F2F22D/DL001Z; Biological: F2F22E/DL001Z; Biological: F2F22F/DL001Z; Combination product: Control 1; Biological: F2F23D/DL001Z-NH; Biological: F2F23A/DL001Z-NH; Biological: F2F23B/DL001Z-NH; Combination product: Control 2; Biological: F2F23C/DL001Z-NH; Combination product: Control 3

• Study Type: Interventional
• Enrollment (Actual): 1275
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2000
    • GSK Investigational Site
  • Edegem, Belgium, 2610
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Ieper, Belgium, 8900
    • GSK Investigational Site
  • Kluisbergen, Belgium, 9690
    • GSK Investigational Site
  • Mechelen, Belgium, 2800
    • GSK Investigational Site
  • Tielt, Belgium
    • GSK Investigational Site
  • Zwalm, Belgium, 9630
    • GSK Investigational Site
• Canada
  • Quebec, Canada, G1W 4R4
    • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • GSK Investigational Site
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7Y8
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • GSK Investigational Site
• South Africa
  • Buffalo, South Africa, 5201
    • GSK Investigational Site
  • Cape Town, South Africa, 7530
    • GSK Investigational Site
  • Johannesburg, South Africa, 2113
    • GSK Investigational Site
  • Tembisa, South Africa, 1632
    • GSK Investigational Site
• United States
  • Florida
    • Hialeah, Florida, United States, 33012
      • GSK Investigational Site
    • Miami, Florida, United States, 33186
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • GSK Investigational Site
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • GSK Investigational Site
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • GSK Investigational Site
  • Michigan
    • Dearborn, Michigan, United States, 48127
      • GSK Investigational Site
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • GSK Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • GSK Investigational Site
    • Syracuse, New York, United States, 13057
      • GSK Investigational Site
  • North Carolina
    • Denver, North Carolina, United States, 80110
      • GSK Investigational Site
    • Greensboro, North Carolina, United States, 27408
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 33147
      • GSK Investigational Site
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • GSK Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • GSK Investigational Site
  • Texas
    • Fort Worth, Texas, United States, 76135
      • GSK Investigational Site
    • Houston, Texas, United States, 48076
      • GSK Investigational Site
    • Tomball, Texas, United States, 77375
      • GSK Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • GSK Investigational Site
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration.
• Healthy participants or medically stable participants as established by medical history, clinical examination, and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment 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 enrollment.
• Body mass index (BMI) >=18 kilograms per meter square (kg/m^2) and less than or equal to (<=) 35 kg/m^2.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the participant prior to performing any study-specific procedure.
• Female participants of non-childbearing potential may be enrolled in the study.
• Female participants of childbearing potential may be enrolled in the study if the participant:
• has practiced adequate contraception for 28 days prior to study intervention administration, and
• has a negative pregnancy test on the day of study intervention administration, and
• has agreed to continue adequate contraception for at least 1 month after study intervention administration

Exclusion Criteria:

Medical conditions

• Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality.

  *The investigator should use the clinical judgment to decide which abnormalities are clinically significant.

• Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
• Current or past malignancy, unless completely resolved without clinically significant sequelae for >5 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required). However, in Phase 2, HIV-infected individuals may be enrolled if participants 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 (mm^3) and their viral load has been undetectable (i.e., HIV-RNA less than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
• History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA coronavirus disease 2019 (COVID-19) vaccine.
• Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics).
• History of, or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

• Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration.

• Phase 1: Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. Phase 2: Administration of a vaccine not foreseen by the study protocol in the period starting 15 days (Day -15) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.

  *In case emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

• 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.
• Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use at any time during the study period.
• 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. Administration of monoclonal antibodies specifically directed against the spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), for treatment of COVID-19 disease is allowed.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent >=20 milligrams (mg)/day. Inhaled, topical and intraarticular steroids are allowed.

Other exclusions

• 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).
• Pregnant or lactating female.
• Bedridden participants.
• Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
• Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
• Any study personnel or their immediate dependents, family, or household members.
• Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

21

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flu mRNA_Ph1_1 Younger Adults (YA) Group; YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.	Biological: F2C22C/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_2 YA Group; YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.	Biological: F2B22A/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_3 YA Group; YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.	Biological: F2B22B/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_4 YA Group; YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.	Biological: F2B22C/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_5 YA Group; YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.	Biological: F2B22D/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_6 YA Group; YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.	Biological: F2B22E/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_7 YA Group; YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.	Biological: F2F22A/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_8 YA Group; YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.	Biological: F2F22B/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_9 YA Group; YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.	Biological: F2F22C/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_10 YA Group; YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.	Biological: F2F22D/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_11 YA Group; YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.	Biological: F2F22E/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph1_12 YA Group; YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.	Biological: F2F22F/DL001Z; Study intervention was administered intramuscularly in Phase 1, at Day 1.
Active Comparator: Control Ph1_YA Group; YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.	Combination product: Control 1; Control vaccine was administered intramuscularly in Phase 1, at Day 1.
Experimental: Flu mRNA_Ph2_1_YA Group; YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.	Biological: F2F23D/DL001Z-NH; Study intervention was administered intramuscularly in Phase 2, at Day 1.
Experimental: Flu mRNA_Ph2_2_YA Group; YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.	Biological: F2F23A/DL001Z-NH; Study intervention was administered intramuscularly in Phase 2, at Day 1.
Experimental: Flu mRNA_Ph2_3_YA Group; YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.	Biological: F2F23B/DL001Z-NH; Study intervention was administered intramuscularly in Phase 2, at Day 1.
Active Comparator: Control_Ph2_YA Group; YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.	Combination product: Control 2; Control vaccine was administered intramuscularly in Phase 2, at Day 1.
Experimental: Flu mRNA_Ph2_1_Older adults (OA) Group; OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.	Biological: F2F23A/DL001Z-NH; Study intervention was administered intramuscularly in Phase 2, at Day 1.
Experimental: Flu mRNA_Ph2_2_OA Group; OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.	Biological: F2F23B/DL001Z-NH; Study intervention was administered intramuscularly in Phase 2, at Day 1.
Experimental: Flu mRNA_Ph2_3_OA Group; OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.	Biological: F2F23C/DL001Z-NH; Study intervention was administered intramuscularly in Phase 2, at Day 1.
Active Comparator: Control_Ph2_OA Group; OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.	Combination product: Control 3; Control vaccine was administered intramuscularly in Phase 2, at Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)	Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.	Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic AEs	Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.	Day 1 to Day 7
Number of Participants Reporting Any Unsolicited AEs	An unsolicited AE is defined as an AE that was 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.	Day 1 to Day 28
Number of Participants Reporting Serious Adverse Events (SAEs)	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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.	Day 1 to Day 183
Number of Participants Reporting AEs of Special Interest (AESIs)	The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.	Day 1 to Day 183
Number of Participants Reporting Medically Attended Events (MAEs)	MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.	Day 1 to Day 183
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry	Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.	At Day 8 compared to baseline (Day 1)
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry	Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.	At Day 29 compared to baseline (Day 1)
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer	Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	At Day 29
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29	GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)	SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	From Day 1 to Day 29
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)	SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	At Day 1
Percentage of Participants With Antigen 1 Antibody SPR	Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	At Day 29
GMT of Antigen 2 Antibody Titer		At Day 29
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29		From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 2 Antibody SCR		From Day 1 to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMT of Antigen 1 Antibody Titer	Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	At Day 92
GMT of Antigen 1 Antibody Titer	Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	At Day 183
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92	Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	From Day 1 (baseline) to Day 92
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183	Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	From Day 1 (baseline) to Day 183
Percentage of Participants With Antigen 1 Antibody SPR	Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.	At Day 183
GMT of Antigen 2 Antibody Titer		At Day 92 and Day 183
GMI of Antigen 2 Antibody Titer		From Day 1 to Day 92 and Day 1 to Day 183

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: CureVac
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): December 18, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Influenza; Immunogenicity; Reactogenicity; mRNA vaccine; Healthy older adults; Healthy younger adults
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: 217884; 2022-502308-66-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No