Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK4382276A Dose level 1
GSK4382276A · 1 trial · 1 indication
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.
Assessed solicited systemic events included fever, chills, headache, myalgia, arthralgia and fatigue. Any = occurrence of the symptom regardless of intensity grade.
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.
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.
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).
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.
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.
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.
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.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer ≥ 1:40.
| Arm | Type | Description |
|---|---|---|
| Flu mRNA_Dose level 1_Younger adults (YA) | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On 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 | EXPERIMENTAL | On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study. |
| Pooled Control_YA | ACTIVE_COMPARATOR | On 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) | EXPERIMENTAL | On Day 1, OA participants received Flu mRNA at Dose Level 7. |
| Control_OA | ACTIVE_COMPARATOR | On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control. |
| Name | Type | Description |
|---|---|---|
| GSK4382276A Dose level 1 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 2 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 3 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 4 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 5 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 6 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 7 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 8 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 9 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| GSK4382276A Dose level 10 | BIOLOGICAL | Single dose of intervention administered at Day 1 |
| FDQ21A-NH | COMBINATION_PRODUCT | Single dose of intervention administered at Day 1 |
| FDQ22A-NH | COMBINATION_PRODUCT | Single dose of intervention administered at Day 1 |
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 med...
GSK4382276A is an investigational monoclonal antibody developed by GSK plc for influenza in humans. It has been studied in a Phase 1 clinical trial in healthy younger and older adults. It is not an approved product and remains in clinical development.
GSK4382276A is being developed for the prevention or management of human influenza, an infectious disease. Its only recorded clinical study enrolled healthy adult volunteers aged 18 years and older, including both younger and older adults, to assess safety, reactogenicity and immune response.
GSK4382276A is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 study of the monoclonal antibody in influenza conducted across Belgium, Canada and Spain.
GSK4382276A is in Phase 1 development. Its single recorded trial, NCT05446740, was a Phase 1 study that has been completed. The drug is investigational and has not been approved for any indication.
GSK4382276A has been evaluated in one clinical trial, NCT05446740, titled a study on the safety, reactogenicity and immune response of a vaccine against influenza in healthy younger and older adults. The Phase 1 trial enrolled 324 participants, was randomized, double blind and active controlled, and is completed.
GSK4382276A Dose level 1 is an alternative name used for GSK4382276A, referring to a specific dose level within its clinical program. Both names refer to the same investigational monoclonal antibody being developed by GSK plc for human influenza.