Loading clinical trials...

A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults

A Phase 1/2, Randomized, Controlled Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Investigational Flu Seasonal/SARS-CoV-2 Combination mRNA Vaccine in Adults

NCT06680375•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will evaluate the reactogenicity, safety, and immune response of Flu Seasonal/SARS-CoV-2 mRNA (mRNA Flu/COVID-19) combination vaccine. The flu portion will target multiple strains of the flu virus, while the COVID-19 part will focus on the spike protein of the SARS-CoV-2 virus. Both parts of this vaccine have been tested individually before. This will be the first study to test the combined vaccine in humans in healthy adult participants.

Detailed Description

Click here to enter text.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

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, return for follow-up visits).
•Written informed consent obtained from the participant prior to performance of any study-specific procedure.
•A male or female 18-64 years of age (YA: 18-64) at the time of the study intervention administration.
•Participants must have a body mass index (BMI) \>=18 kg/m² and less than equal to (\<=) 40 kg/m2.
•Healthy participants or medically stable patients as established by medical history, clinical examination and (safety laboratory assessments). 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.
•Prior receipt of a COVID-19 vaccine. This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized COVID-19 vaccine. The last COVID-19 vaccination must have been received at least 90 days prior to randomization.
•Women of non-childbearing potential may be enrolled in the study.
•Women of childbearing potential may be enrolled in the study if the participant:
•* has practiced adequate contraception for 4 weeks 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 8 weeks after completion of the study intervention administration.

Exclusion Criteria

•Medical conditions
•Any clinically significant hematological, biochemical laboratory abnormality.
•Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
•A documented history of confirmed SARS-CoV-2 infection within 90 days before study vaccination.
•Has had known close contact with anyone who had confirmed influenza or a confirmed SARS-CoV-2 infection within 2 weeks before study vaccination.
•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.
•Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol, or may interfere with successful completion of the study.
•Has a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Any history of an immunosuppressive or immunodeficient condition resulting from disease (e.g., HIV infection or congenital immunodeficiency).
+21 more criteria

Locations (9)

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Rochester, New York, United States

Key Dates

Start Date

November 11, 2024

Primary Completion Date

June 9, 2025

Completion Date

June 9, 2025

Last Updated

September 11, 2025

Enrollment

106

ACTUAL participants

Conditions

COVID-19

Interventions

Flu Seasonal /SARS-CoV-2 mRNA Dose 1

COMBINATION_PRODUCT

Flu Seasonal /SARS-CoV-2 mRNA Dose 2

COMBINATION_PRODUCT

Flu Seasonal mRNA

COMBINATION_PRODUCT

SARS-CoV-2 mRNA Dose 1

COMBINATION_PRODUCT

SARS-CoV-2 mRNA Dose 2

COMBINATION_PRODUCT

Licensed Flu Seasonal

COMBINATION_PRODUCT

Licensed COVID-19 mRNA

COMBINATION_PRODUCT

Placebo

DRUG

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

RECRUITINGNA

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Dime La VerDAD: Verify, Debunk, and Disseminate

Positron Emission Tomography (PET) Imaging of Thrombosis