Influenza, Human+COVID-19Phase 1NCT07464314
A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
A Phase 1 study testing Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine, Licensed Seasonal Influenza Vaccine and Licensed COVID-19 Vaccine in people with Influenza, Human+COVID-19, run by GlaxoSmithKline at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Influenza, Human+COVID-19
- What is being tested?
- Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine, Licensed Seasonal Influenza Vaccine and Licensed COVID-19 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 12 sitesUnited States
- Study dates
- 9 Mar 2026to 3 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver.
- Informed consent obtained from the participant prior to performance of any study-specific procedure.
- A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.
- Healthy participants or medically stable patients as established by medical history and clinical examination.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any clinically significant laboratory abnormality.
- History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration.
- History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
- Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for >5 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
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- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests.
- History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine.
- History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
- Administration of any influenza vaccine within 181 days before the study intervention administration (Day -180 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
- Administration of a SARS-CoV-2 antigen-containing vaccine in the period starting 91 days before the study intervention administration (Day -90 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
- Administration of any mRNA-based vaccine in the period starting 29 days before the study intervention administration (Day -28 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
- Administration of any other vaccine not foreseen by the study protocol in the period starting 29 days (Day -28 to Day 1) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
GSK Investigational Site
Anniston, Alabama, 36207
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Austin, Texas, 78705
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Charlottesville, Virginia, 22911
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fair Oaks, California, 95628
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Little Rock, Arkansas, 72204
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33186
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami Lakes, Florida, 33016
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Newport News, Virginia, 23606
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Diego, California, 92123
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seattle, Washington, 98104
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Stockbridge, Georgia, 30281
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
West Palm Beach, Florida, 33409
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1, Observer-Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of an Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
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.
- Conditions
- Influenza, Human+COVID-19
- Being tested
- Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine, Licensed Seasonal Influenza Vaccine, Licensed COVID-19 Vaccine
- Keywords
- Influenza, COVID-19, SARS-CoV-2, mRNA vaccine, combination vaccine, immunogenicity, older adults
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) VaccineBiological
Flu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection.
Licensed Seasonal Influenza VaccineBiological
License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
Licensed COVID-19 VaccineBiological
Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine |
| 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). Receives: Biological: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine |
| 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). Receives: Biological: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine |
| Licensed Seasonal Influenza Vaccine Group | Active comparator | Participants receive a single intramuscular administration of a licensed seasonal Flu vaccine. Receives: Biological: Licensed Seasonal Influenza Vaccine |
| Licensed COVID-19 Vaccine Group | Active comparator | Participants receive a single intramuscular administration of a licensed COVID-19 vaccine. Receives: Biological: Licensed COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 3
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Measured: Day 1 to Day 8
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Day 28
Number of Participants with Serious Adverse Events (SAEs)
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.
Measured: 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).
Measured: 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.
Measured: Day 1 to Day 181
Secondary outcomes (10)
Geometric Mean Titer (GMT) Of Antigen 1 Titer
Measured: At Day 29
Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)
Measured: Day 1 to Day 29
Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)
Measured: At Day 1 and Day 29
Geometric Mean Increase (GMI) of Antigen 1 Titer
Measured: Day 1 to Day 29
GMT Of Antigen 2 Titer
Measured: At Day 29
Percentage of Participants with Antigen 2 SCR
Measured: Day 1 to Day 29
GMI of Antigen 2 Titer
Measured: Day 1 to Day 29
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Measured: At Day 29
Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Measured: Day 1 to Day 29
GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Measured: Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start9 Mar 2026
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, Human+COVID-19Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464314
- Sponsor's protocol ID
- 300768
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Observer-Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of an Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
- ClinicalTrials.gov ID
- NCT07464314
- Acronym / sponsor ID
- 300768
- Conditions
- Influenza, Human+COVID-19
- Keywords
- Influenza, COVID-19, SARS-CoV-2, mRNA vaccine, combination vaccine, immunogenicity, older adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FLU/COVm_Dose Level 1 | Experimental | Biological: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) VaccineParticipants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 1 (Lowest dose). |
| FLU/COVm_Dose Level 2 | Experimental | Biological: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) VaccineParticipants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 2 (Medium dose). |
| FLU/COVm_Dose Level 3 | Experimental | Biological: Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) VaccineParticipants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 3 (Highest dose). |
| Licensed Seasonal Influenza Vaccine Group | Active comparator | Biological: Licensed Seasonal Influenza VaccineParticipants receive a single intramuscular administration of a licensed seasonal Flu vaccine. |
| Licensed COVID-19 Vaccine Group | Active comparator | Biological: Licensed COVID-19 VaccineParticipants receive a single intramuscular administration of a licensed COVID-19 vaccine. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver.
- Informed consent obtained from the participant prior to performance of any study-specific procedure.
- A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.
- Healthy participants or medically stable patients as established by medical history and clinical examination.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (15 listed)
- Any clinically significant laboratory abnormality.
- History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration.
- History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
- Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for >5 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) VaccineFlu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection. | Biological | FLU/COVm_Dose Level 1, FLU/COVm_Dose Level 2, FLU/COVm_Dose Level 3 |
| Licensed Seasonal Influenza VaccineLicense Seasonal Influenza Vaccine will be administered as a single intramuscular dose. | Biological | Licensed Seasonal Influenza Vaccine Group |
| Licensed COVID-19 VaccineLicensed COVID-19 Vaccine will be administered as a single intramuscular dose. | Biological | Licensed COVID-19 Vaccine Group |
Primary outcome
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention
Time frame: Day 1 to Day 3
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.
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Time frame: Day 1 to Day 8
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Time frame: Day 1 to Day 29
Number of Participants with Solicited Administration Site Adverse Events (AEs)
Time frame: Day 1 to Day 7
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
Number of Participants with Solicited Systemic AEs
Time frame: Day 1 to Day 7
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills.
Number of Participants with Unsolicited AEs
Time frame: Day 1 to Day 28
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.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 181
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.
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Day 181
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).
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 to Day 181
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.
10 secondary outcomes
Geometric Mean Titer (GMT) Of Antigen 1 Titer
Time frame: At Day 29
Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)
Time frame: Day 1 to Day 29
Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)
Time frame: At Day 1 and Day 29
Geometric Mean Increase (GMI) of Antigen 1 Titer
Time frame: Day 1 to Day 29
GMT Of Antigen 2 Titer
Time frame: At Day 29
Percentage of Participants with Antigen 2 SCR
Time frame: Day 1 to Day 29
GMI of Antigen 2 Titer
Time frame: Day 1 to Day 29
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Time frame: At Day 29
Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Time frame: Day 1 to Day 29
GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Time frame: Day 1 to Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine, Licensed Seasonal Influenza Vaccine and Licensed COVID-19 Vaccine in people with Influenza, Human+COVID-19, run by GlaxoSmithKline at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention (time frame: Day 1 to Day 3). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.