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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522278-35 | EudraCT Number |
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"The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flu mRNA_1_YA | Experimental | Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1. |
|
| Flu mRNA_2_YA | Experimental | Eligible YA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1. |
|
| Comparator_1_YA | Active Comparator | Eligible YA participants receive a single dose of comparator 1 at Day 1. |
|
| Comparator_2_YA | Active Comparator | Eligible YA participants receive a single dose of comparator 2 at Day 1. |
|
| Flu mRNA_1_OA | Experimental | Eligible Older Adults (OA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1. |
|
| Flu mRNA_2_OA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flu mRNA (Formulation A) | Biological | One dose of Flu mRNA (Formulation A) received intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) Ratio of Antigen 1 Titer | At Day 29 | |
| Geometric Mean Increase (GMI) of Antigen 1 Titer | From Day 1 to Day 29 | |
| Percentage of Participants with Antigen 1 Seroconversion Rate (SCR) | From Day 1 to Day 29 | |
| Percentage of Participants with Antigen 1 Seroprotection Rate (SPR) | At Day 1 and Day 29 | |
| Number of Participants with Solicited Administration Site Adverse Events (Aes) | The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. | From Day 1 to Day 7 |
| Number of Participants with Solicited Systemic Aes | The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (>=) 38 °C/100.4°F regardless the location of measurement. | From Day 1 to Day 7 |
| Number of Participants with Unsolicited Aes | An unsolicited AE is 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. | From Day 1 to Day 28 |
| Number of Participants with Serious Adverse Events (SAEs) | SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment. |
| Measure | Description | Time Frame |
|---|---|---|
| GMT Ratio of Antigen 2 Titer | At Day 29 | |
| GMI of Antigen 2 Titer | From Day 1 to Day 29 | |
| Percentage of Participants with Antigen 2 SCR |
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Inclusion Criteria:
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
A male or female at least 18 YOA at the time of the screening.
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, 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 enrollment.
Female participants of non-childbearing potential may be enrolled in the clinical study.
Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
Body mass index (BMI) between18 kg/m^² and 33kg/m^².
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anniston | Alabama | 36207 | United States | ||
| GSK Investigational Site |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
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 asset(s) with development terminated across all indications.
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.
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This is an Observer-blind study.
| Experimental |
Eligible OA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1. |
|
| Comparator_1_OA | Experimental | Eligible OA participants receive a single dose of comparator 1 at Day 1. |
|
| Comparator_2_OA | Active Comparator | Eligible OA participants receive a single dose of comparator 2 at Day 1. |
|
| Comparator_3_OA | Active Comparator | Eligible OA participants receive a single dose of comparator 3 at Day 1. |
|
| Flu mRNA (Formulation B) | Biological | One dose of Flu mRNA (Formulation B) received intramuscularly. |
|
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| Comparator 1 | Combination Product | One dose of Comparator 1 received intramuscularly. |
|
| Comparator 2 | Combination Product | One dose of Comparator 2 received intramuscularly. |
|
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| Comparator 3 | Combination Product | One dose of Comparator 3 received intramuscularly. |
|
| From Day 1 to Day 181 (study end) |
| Number of Participants with Adverse Events of Special Interest (AESIs) | From Day 1 to Day 181 (study end) |
| Number of Participants with Medically Attended Adverse Events (MAAEs) | A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional. | From Day 1 to Day 181 (study end) |
| Number of Participants with any Laboratory abnormalities | Click here to enter text. | From Day 1 to Day 29 |
| From Day 1 to Day 29 |
| Fair Oaks |
| California |
| 95628 |
| United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Hialeah | Florida | 33012 | United States |
| GSK Investigational Site | Jupiter | Florida | 33458 | United States |
| GSK Investigational Site | Miami | Florida | 33186 | United States |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | United States |
| GSK Investigational Site | Valparaiso | Indiana | 46383 | United States |
| GSK Investigational Site | Lenexa | Kansas | 66219 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01103 | United States |
| GSK Investigational Site | Carson City | Nevada | 89706 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27408 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44122 | United States |
| GSK Investigational Site | North Charleston | South Carolina | 29405 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | DeSoto | Texas | 75115 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76135 | United States |
| GSK Investigational Site | Newport News | Virginia | 23606 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
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