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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
324
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
Single dose of intervention administered at Day 1
GSK Investigational Site
Edegem, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
Time frame: 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.
Time frame: 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.
Time frame: At Day 29 compared to baseline (Day 1)
Geometric Mean Titers (GMT) of Anti-vaccine Antibody Titers
Time frame: At Day 1
GMT of Anti-vaccine Antibody Titers
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 22
GMT of Anti-vaccine Antibody Titers
Time frame: At Day 62 and Day 183
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 62
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Time frame: From Day 1 to Day 62
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 183
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Time frame: From Day 1 to Day 183
Percentage of Participants With Anti-vaccine Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titers ≥ 1:40.
Time frame: At Day 62 and Day 183