F2C22C/DL001Z
BiologicalStudy intervention was administered intramuscularly in Phase 1, at Day 1.
NCT Number: NCT05823974
The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).
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Notify Me18 year–85 year
All sexes
Interventional
Phase 1 / Phase 2
GSK Investigational Site, Antwerp, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medical conditions
*The investigator should use the clinical judgment to decide which abnormalities are clinically significant.
Prior/Concomitant therapy
*In case emergency mass vaccination for an unforeseen public health threat is recommended and/or 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 vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Other exclusions
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Control vaccine was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Time frame: Day 1 to Day 7
Assessed solicited administration site events included pain, redness (Erythema), swelling, 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 or relation to the study vaccination.
Time frame: Day 1 to Day 7
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 28
An unsolicited AE is defined as an AE 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 include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 183
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 183
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). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 183
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: At Day 8 compared to baseline (Day 1)
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)
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
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 (baseline) to Day 29
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 to Day 29
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. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 1
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 29
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 29
Time frame: From Day 1 (baseline) to Day 29
Time frame: From Day 1 to Day 29
Time frame: At Day 92
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 183
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 (baseline) to Day 92
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 (baseline) to Day 183
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 183
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 92 and Day 183
Time frame: From Day 1 to Day 92 and Day 1 to Day 183
GlaxoSmithKline
Industry
A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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