Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Flu Pandemic mRNA_Dose level 1 · 1 trial · 1 indication
The assessed solicited administration site events are pain at administration site, redness at administration site, swelling at administration site and lymphadenopathy.
The assessed solicited systemic events are fever, headache, myalgia, arthralgia, fatigue, and chills. Fever is defined as temperature greater than or equal to (\>=)38 degrees Celsius (°C)/ 100.4 Fahrenheit (°F) regardless the location of measurement.
An unsolicited AE is 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 nonserious AEs.
An MAAE is defined as an unsolicited AE for which the participant receives medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
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, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product.
Events considered as AESIs are severe hypersensitivity reactions and myocarditis/pericarditis.
The assessed solicited administration site events are pain at administration site, redness at administration site, swelling at administration site and lymphadenopathy.
The assessed solicited systemic events are fever, headache, myalgia, arthralgia, fatigue, and chills. Fever is defined as temperature \>= 38°C/100.4°F regardless the location of measurement. The preferred location for measuring temperature is axillary.
An unsolicited AE is 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 nonserious AEs.
MAAE is defined as an unsolicited AE for which the participant receives medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
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, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product.
Events considered as AESIs are severe hypersensitivity reactions, Aminotransferase (AT) elevation and myocarditis/pericarditis.
HI seroconversion is defined as a post-dose titer ≥1:40 in the serum of participants with pre-dose titer below 1:10 or as a ≥4-fold rise in post dose HI titers with pre- dose titer ≥1:10.
| Arm | Type | Description |
|---|---|---|
| Flu mRNA_Ph1_1_YA | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_2_YA | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_3_YA | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_4_YA | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_5_YA | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 1, at Day 1 and at Day 22. |
| Placebo_Ph1_YA | PLACEBO_COMPARATOR | YA participants receive 2 doses of Placebo during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_1_OA | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_2_OA | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_3_OA | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_4_OA | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph1_5_OA | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 1, at Day 1 and at Day 22. |
| Placebo_Ph1_OA | PLACEBO_COMPARATOR | OA Adult participants receive 2 doses of Placebo during Phase 1, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_1_YA Part A | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_2_YA Part A | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_3_YA Part A | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_4_YA Part A | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_5_YA Part A | EXPERIMENTAL | YA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 2 Part A, at Day 1 and at Day 22. |
| Placebo_Ph2_YA Part A | PLACEBO_COMPARATOR | YA participants receive 2 doses of Placebo during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_1_OA Part A | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_2_OA Part A | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_3_OA Part A | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_4_OA Part A | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2_5_OA Part A | EXPERIMENTAL | OA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 2 Part A, at Day 1 and at Day 22. |
| Placebo_Ph2_OA Part A | PLACEBO_COMPARATOR | OA participants receive 2 doses of Placebo during Phase 2 Part A, at Day 1 and at Day 22. |
| Flu mRNA_Ph2 Part B | EXPERIMENTAL | Participants receive 2 dose of Flu Pandemic mRNA dose level 6 in Phase 2 Part B, at Day 1 and at Day 22. |
| Influenza Virus Vaccine_Ph2 Part B | ACTIVE_COMPARATOR | Participants receive 2 doses of influenza virus vaccine administered in Phase 2 Part B, at Day 1 and at Day 22. |
| Placebo_Ph2 Part B | PLACEBO_COMPARATOR | Participants receive 2 doses of Placebo during Phase 2 Part B, at Day 1 and at Day 22. |
| Name | Type | Description |
|---|---|---|
| Flu Pandemic mRNA_Dose level 1 | BIOLOGICAL | 2 doses of study intervention are administered to participants intramuscularly. |
| Flu Pandemic mRNA_Dose level 2 | BIOLOGICAL | 2 doses of study intervention are administered to participants intramuscularly. |
| Flu Pandemic mRNA_ Dose level 3. | BIOLOGICAL | 2 doses of study intervention are administered to participants intramuscularly. |
| Flu Pandemic mRNA_ Dose level 4 | BIOLOGICAL | 2 doses of study intervention are administered to participants intramuscularly. |
| Flu Pandemic mRNA_Dose level 5 | BIOLOGICAL | 2 doses of study intervention are administered to participants intramuscularly. |
| Flu Pandemic mRNA_Dose level 6 | BIOLOGICAL | 2 dose of study intervention is administered to participants intramuscularly. |
| Influenza virus vaccine | BIOLOGICAL | 2 doses of Influenza virus vaccine are administered to participants intramuscularly. |
| Placebo | DRUG | 2 doses of Placebo are administered intramuscularly to participants in Phase 1 and Phase 2 Part A and 2 dose is administered to participants in Phase 2 Part B. |
Inclusion Criteria: * A male or female between and including 18 and 64 yoa (i.e., 64 years + 364 days; YAs) or between and including 65 and 85 yoa (i.e., 85 years + 364 days; OAs) at the time of the first study intervention administration. * Participants, who, in the opinion of the investigator, ca...
Flu Pandemic mRNA_Dose level 1 is an investigational vaccine being developed for the prevention of influenza in humans, specifically targeting pandemic H5N1 influenza virus. It is designed to be used in healthy younger and older adults to assess safety, reactogenicity, and immune response.
Flu Pandemic mRNA_Dose level 1 is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
Flu Pandemic mRNA_Dose level 1 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under clinical investigation.
Flu Pandemic mRNA_Dose level 1 has been studied in one clinical trial, identified as NCT06382311. This Phase 1 study, titled 'A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults,' was conducted in the United States and has been completed.
Flu Pandemic mRNA_Dose level 1 is classified as a monoclonal antibody modality, although it is being developed as a vaccine against pandemic H5N1 influenza. The clinical trial evaluates its safety, reactogenicity, and immune response in healthy adults.
The Phase 1 trial for Flu Pandemic mRNA_Dose level 1, NCT06382311, was a randomized, double-blind, placebo-controlled study. It enrolled 991 participants aged 18 years and older, including both younger and older healthy adults, and was conducted in the United States.