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About
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.
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Enrollment
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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, 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:
Exclusion criteria
Medical conditions
Prior/Concomitant therapy
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.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
Administration of immunoglobulins and/or any blood products or plasma derivatives within 3 months before study vaccination through end of study.
Prior/Concurrent clinical study experience
• 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.
Other exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
107 participants in 6 patient groups
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Central trial contact
US GSK Clinical Trials Call Center; EU GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
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