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RSV_PreF3 Vaccine adjuvanted with AS01B · 1 trial · 1 indication
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling is scored 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 with a diameter larger than (\>) 20 millimeters (mm).
Assessed solicited general AEs solicited were: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.
Assessed solicited general AEs solicited are: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms including (nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
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 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 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 |
|---|---|---|
| RSV_PreF3_AS01B Group | EXPERIMENTAL | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
| Name | Type | Description |
|---|---|---|
| RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B | BIOLOGICAL | Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. |
| Placebo | DRUG | Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. |
Inclusion Criteria: * 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 performance of any study specific procedure. * A male or female between, and including, 60 and 80 years of...
The RSV_PreF3 Vaccine adjuvanted with AS01B is an investigational vaccine developed by GSK plc for the prevention of respiratory syncytial virus infections. It combines a prefusion-stabilized RSV F protein antigen with the AS01B adjuvant system and is being studied in older adults.
It is being developed for the prevention of respiratory syncytial virus infections. RSV is a common respiratory pathogen that can cause serious illness in older adults. The candidate vaccine is intended to protect this population by inducing an immune response against the virus.
GSK plc, which trades under the ticker GSK, is the developer of the RSV_PreF3 Vaccine adjuvanted with AS01B. The company also refers to the candidate as GSK3844766A. GSK is a global pharmaceutical company with an established vaccine portfolio.
The RSV_PreF3 Vaccine adjuvanted with AS01B is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 1 program has been completed, and the candidate remains in clinical development.
The candidate has been studied in one completed Phase 1 trial, NCT04090658, titled a study to test GSK's RSV candidate vaccine's safety and immune response in Japanese older adults. The trial enrolled 40 participants aged 60 years and older in Japan and was randomized, double-blind, and placebo-controlled.
Yes. The RSV_PreF3 Vaccine adjuvanted with AS01B is also known as RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B. GSK3844766A is GSK's internal designation for the same candidate vaccine, so the two names refer to the same investigational asset.