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A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

A Phase 1 Randomized, Dose Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an mRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults

NCT05446740•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A male or female between and including 18 and 45 years of age (YAs) or between and including 60 and 80 years of age (OAs) at the time of the study intervention administration. The age of sentinel participants in OA category will be limited to maximum 70 years.
•Healthy or medically stable participants as established by medical history, safety laboratory assessments and clinical examination.
•Body mass index \>= 18 kg/m\^2 and \<= 32 kg/m\^2.
•Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•Written informed consent obtained from the participant prior to performing any study-specific procedure.
•Female participants of non-childbearing potential may be enrolled in the study.
•Female participants of childbearing potential may be enrolled in the study if the participant:
•* has practiced adequate contraception for 28 days 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 1 month after study intervention administration.

Exclusion Criteria

•Medical conditions
•Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or review of the participant's medical record.
•Any clinically significant hematological coagulation or urine analysis laboratory abnormality.
•\* The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
•Current or past malignancy, unless completely resolved without sequelae for \>5 years.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required).
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, poly-ethylene-glycol, egg protein and aminoglycoside antibiotics).
•Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
+17 more criteria

Locations (7)

GSK Investigational Site

Edegem, Belgium

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

Key Dates

Start Date

August 9, 2022

Primary Completion Date

March 26, 2024

Completion Date

March 26, 2024

Last Updated

March 10, 2026

Enrollment

324

ACTUAL participants

Conditions

Influenza, Human

Interventions

GSK4382276A Dose level 1

BIOLOGICAL

GSK4382276A Dose level 2

BIOLOGICAL

GSK4382276A Dose level 3

BIOLOGICAL

GSK4382276A Dose level 4

BIOLOGICAL

GSK4382276A Dose level 5

BIOLOGICAL

GSK4382276A Dose level 6

BIOLOGICAL

GSK4382276A Dose level 7

BIOLOGICAL

GSK4382276A Dose level 8

BIOLOGICAL

GSK4382276A Dose level 9

BIOLOGICAL

GSK4382276A Dose level 10

BIOLOGICAL

FDQ21A-NH

COMBINATION_PRODUCT

FDQ22A-NH

COMBINATION_PRODUCT

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covid19 InfectionInfluenza, Human

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Influenza, HumanInfluenza a+2 more

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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: March 10, 2026Data 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 on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

Inclusion Criteria

Exclusion Criteria

Covid-19 and Influenza Oral Vaccine Study

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