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
2 other identifiers
interventional
324
3 countries
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedStudy Start
First participant enrolled
August 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2024
CompletedResults Posted
Study results publicly available
March 10, 2026
CompletedMarch 10, 2026
February 1, 2026
1.6 years
June 28, 2022
September 26, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included pain, erythema/redness, swelling and Lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included fever, chills, headache, myalgia, arthralgia and fatigue. Any = occurrence of the symptom regardless of intensity grade.
Day 1 to Day 7
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AEs is an AEs 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. Unsolicited AEs must have been communicated by a participant who has signed the informed consent or through his/her caregiver. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Day 1 to Day 28
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
Day 1 to Day 183
Number of Participants Reporting AEs of Special Interest (AESIs)
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
Day 1 to Day 183
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, Clinical Chemistry, Coagulation and Urine Analysis
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
At Day 8 compared to baseline (Day 1)
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology,Clinical Chemistry, Coagulation and Urine Analysis
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
At Day 29 compared to baseline (Day 1)
Geometric Mean Titers (GMT) of Anti-vaccine Antibody Titers
At Day 1
GMT of Anti-vaccine Antibody Titers
At Day 22
Geometric Mean Increase (GMI) of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 22
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titers over the Day 1 anti-vaccine antibody titers.
From Day 1 to Day 22
Percentage of Participants With Anti-vaccine Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer ≥ 1:40 or a pre-dose anti-vaccine antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer.
From Day 1 to Day 22
Percentage of Participants With Anti-vaccine Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer ≥ 1:40.
At Day 22
Secondary Outcomes (4)
GMT of Anti-vaccine Antibody Titers
At Day 62 and Day 183
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 62
From Day 1 to Day 62
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 183
From Day 1 to Day 183
Percentage of Participants With Anti-vaccine Antibody SPR
At Day 62 and Day 183
Study Arms (13)
Flu mRNA_Dose level 1_Younger adults (YA)
EXPERIMENTALOn Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
Flu mRNA_Dose level 2 _YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
Flu mRNA_Dose level 3_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Flu mRNA_Dose level 4_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
Flu mRNA_Dose level 5_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
Flu mRNA_Dose level 6_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
Flu mRNA_Dose level 7_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
Flu mRNA_ Dose level 8_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
Flu mRNA_Dose level 9_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
Flu mRNA_Dose level 10_YA
EXPERIMENTALOn Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
Pooled Control_YA
ACTIVE COMPARATOROn Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
Flu mRNA_Dose level 7_Older adults (OA)
EXPERIMENTALOn Day 1, OA participants received Flu mRNA at Dose Level 7.
Control_OA
ACTIVE COMPARATOROn Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Interventions
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Significant exposure to persons with influenza or laboratory-confirmed SARS-CoV-2 within 7 days prior to Visit 1 (Day 1) and for whom a SARS-CoV-2 PCR test has not (yet) been confirmed as negative.
- Prior/Concomitant therapy
- Administration of seasonal influenza vaccine within 180 days before enrollment or planned administration up to Visit 4 (Day 29).
- Administration of a vaccine not foreseen by the study protocol in the period starting 28 days before the study intervention administration, or planned administration within 28 days after the study intervention administration\*, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of the type of vaccine).
- \*In case emergency mass vaccination for an unforeseen public health threat is organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days, if necessary, for that mass vaccination vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- CureVaccollaborator
Study Sites (7)
GSK Investigational Site
Edegem, 2650, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Halifax, Nova Scotia, B3J 3G9, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1L 0H8, Canada
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Madrid, 28222, Spain
Related Publications (1)
Leroux-Roels I, De Coster I, Borobia AM, Langley JM, Ochoa Mazarro D, Ruiz-Antoran B, Berre S, Germain S, Knauer C, Koch SD, Mann P, Mesia Vela D, Ovbude LJ, Pardo IA, Srivastava B, Moldt B, Nordgren M. Safety and immunogenicity of an investigational mRNA-lipid nanoparticle-based monovalent influenza vaccine: Results from a phase 1, randomized, dose-escalation study. Hum Vaccin Immunother. 2026 Dec;22(1):2631804. doi: 10.1080/21645515.2026.2631804. Epub 2026 Feb 17.
PMID: 41701031DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Data were collected in an observer-blind manner: participants and site evaluators were blinded, while the sponsor and certain study personnel were aware of treatment assignments. For Dose Levels 1, 2, 5, and 6, data were collected in a single-blind manner-investigators were aware of the intervention, but participants were blinded.
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 7, 2022
Study Start
August 9, 2022
Primary Completion
March 26, 2024
Study Completion
March 26, 2024
Last Updated
March 10, 2026
Results First Posted
March 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.