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This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLU/COVm_Dose Level 1 | Experimental | Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 1 (Lowest dose). |
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| FLU/COVm_Dose Level 2 | Experimental | Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 2 (Medium dose). |
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| FLU/COVm_Dose Level 3 | Experimental | Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 3 (Highest dose). |
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| Licensed Seasonal Influenza Vaccine Group | Active Comparator | Participants receive a single intramuscular administration of a licensed seasonal Flu vaccine. |
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| Licensed COVID-19 Vaccine Group | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine | Biological | Flu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention | The assessed toxicity grades for laboratory value abnormalities will be defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Potentially life-threatening. | Day 1 to Day 3 |
| Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention | Day 1 to Day 8 | |
| Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention | Day 1 to Day 29 | |
| Number of Participants with Solicited Administration Site Adverse Events (AEs) | The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. | 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. | 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. | Day 1 to Day 28 |
| Number of Participants with Serious Adverse Events (SAEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) Of Antigen 1 Titer | At Day 29 | |
| Percentage of Participants with Antigen 1 Seroconversion Rate (SCR) | Day 1 to Day 29 | |
| Percentage of Participants with Antigen 1 Seroprotection Rate (SPR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Anniston | Alabama | 36207 | United States |
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.
Participants receive a single intramuscular administration of a licensed COVID-19 vaccine.
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| Licensed Seasonal Influenza Vaccine | Biological | License Seasonal Influenza Vaccine will be administered as a single intramuscular dose. |
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| Licensed COVID-19 Vaccine | Biological | Licensed COVID-19 Vaccine will be administered as a single intramuscular dose. |
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A 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.
| Day 1 to Day 181 |
| Number of Participants with Adverse Events of Special Interest (AESIs) | The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, Aminotransferase elevation; myocarditis/pericarditis within 6 weeks after study intervention administration and potential immune-mediated diseases (pIMDs). | Day 1 to Day 181 |
| 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. | Day 1 to Day 181 |
| At Day 1 and Day 29 |
| Geometric Mean Increase (GMI) of Antigen 1 Titer | Day 1 to Day 29 |
| GMT Of Antigen 2 Titer | At Day 29 |
| Percentage of Participants with Antigen 2 SCR | Day 1 to Day 29 |
| GMI of Antigen 2 Titer | Day 1 to Day 29 |
| GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) | At Day 29 |
| Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) | Day 1 to Day 29 |
| GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) | Day 1 to Day 29 |
| GSK Investigational Site | Recruiting | Little Rock | Arkansas | 72204 | United States |
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| GSK Investigational Site | Recruiting | Fair Oaks | California | 95628 | United States |
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| GSK Investigational Site | Recruiting | San Diego | California | 92123 | United States |
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| GSK Investigational Site | Recruiting | Miami | Florida | 33186 | United States |
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| GSK Investigational Site | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| GSK Investigational Site | Recruiting | West Palm Beach | Florida | 33409 | United States |
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| GSK Investigational Site | Recruiting | Stockbridge | Georgia | 30281 | United States |
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| GSK Investigational Site | Recruiting | Austin | Texas | 78705 | United States |
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| GSK Investigational Site | Recruiting | Charlottesville | Virginia | 22911 | United States |
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| GSK Investigational Site | Recruiting | Newport News | Virginia | 23606 | United States |
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| GSK Investigational Site | Recruiting | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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