Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RSV Vaccine (GSK3844766A) unadjuvanted low dose
RSV Vaccine unadjuvanted low dose · 1 trial · 1 indication
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (\>) 20 millimeters (mm)
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (\>) 20 millimeters (mm)
Assessed solicited general symptoms include arthralgia, fatigue, fever \[defined as temperature equal to or above 38.0 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], headache, myalgia and shivering.
Assessed solicited general symptoms include arthralgia, fatigue, fever \[defined as temperature equal to or above 38.0 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], headache, myalgia and shivering.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
| Arm | Type | Description |
|---|---|---|
| Group Low Dose_PLAIN_A | EXPERIMENTAL | Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Medium Dose_PLAIN_A | EXPERIMENTAL | Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group High Dose_PLAIN_A | EXPERIMENTAL | Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Placebo_A | PLACEBO_COMPARATOR | Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Low Dose_PLAIN_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Low Dose_AS01E_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Low Dose_AS01B_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Medium Dose_PLAIN_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Medium Dose_AS01E_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Medium Dose_AS01B_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group High Dose_PLAIN_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group High Dose_AS01E_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group High Dose_AS01B_B | EXPERIMENTAL | Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Group Placebo_B | PLACEBO_COMPARATOR | Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm. |
| Name | Type | Description |
|---|---|---|
| RSV Vaccine (GSK3844766A) unadjuvanted low dose | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm |
| RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm |
| RSV Vaccine (GSK3844766A) unadjuvanted medium dose | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| RSV Vaccine (GSK3844766A) unadjuvanted high dose | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm |
| RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B | BIOLOGICAL | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
| Placebo (Saline solution) | DRUG | Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm. |
Inclusion Criteria: For all subjects: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. For Part A: • A male or female between, and ...
RSV Vaccine unadjuvanted low dose is an investigational vaccine developed by GSK plc (ticker: GSK) for the prevention of Respiratory Syncytial Virus Infections. It is an unadjuvanted low-dose formulation studied in older adults. It is in Phase 1 clinical development and has not been approved.
RSV Vaccine unadjuvanted low dose is being studied for the prevention of Respiratory Syncytial Virus Infections. The Phase 1 trial enrolled healthy volunteers aged 18 years and older in the United States and Belgium. It is an investigational vaccine and is not approved for use.
RSV Vaccine unadjuvanted low dose is made by GSK plc, which trades under the ticker GSK. GSK is developing this unadjuvanted low-dose RSV vaccine candidate as part of its RSV vaccine program.
RSV Vaccine unadjuvanted low dose is in Phase 1 clinical development. The single Phase 1 trial, NCT03814590, has been completed. The vaccine is investigational and has not been approved by the FDA.
RSV Vaccine unadjuvanted low dose has been studied in one completed Phase 1 trial, NCT03814590. The trial was a randomized, double-blind, placebo-controlled study that enrolled 1,053 participants in the United States and Belgium to assess safety, reactogenicity, and immune response in older adults.
Yes, RSV Vaccine unadjuvanted low dose is also known as RSV Vaccine (GSK3844766A) unadjuvanted low dose. GSK3844766A is the internal code for this investigational vaccine candidate developed by GSK plc.