Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sa-5Ag half dose non-adjuvanted · 1 trial · 1 indication
The solicited administration site AE(s) assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (\>)100 millimeter (mm) diameter.
The solicited administration site AEs assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (\>)100 millimeter (mm) diameter.
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (\>) 40.0°C/104°F.
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever were assessed. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (\>) 40.0°C/104°F.
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
pIMDs are defined as 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 aetiology.
pIMDs are defined as 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 aetiology.
pIMDs are defined as 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 aetiology.
The Biochemical parameters assessed were: Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and the Haematological parameters assessed were: Haemoglobin, white blood cells (WBC) decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: \<parameter\>,\<grade at baseline\>,\<grade at visit\> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: \<parameter\>,\<any grade at baseline\>,\<grade at visit\> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
| Arm | Type | Description |
|---|---|---|
| Group 1 Dose-escalation Safety Lead-in Epoch: Half dose Non-Adjuvant (Non-Adj) | EXPERIMENTAL | Participants received 1 dose of the half dose formulation of the vaccine on Day 1. |
| Group 2 Dose-escalation Safety Lead-in Epoch: Full dose Non-Adj | EXPERIMENTAL | Participants received 1 dose of the full dose formulation of the vaccine on Day 1. |
| Group 3 Dose-escalation Safety Lead-in Epoch: Half dose Adj | EXPERIMENTAL | Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1. |
| Group 4 Dose-escalation Safety Lead-in Epoch: Full dose Adj | EXPERIMENTAL | Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61. |
| Dose-escalation Safety Lead-in Epoch: Placebo | PLACEBO_COMPARATOR | Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch. |
| Proof of Principle (PoP): Full dose Adj | EXPERIMENTAL | Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61. |
| PoP: Placebo | PLACEBO_COMPARATOR | Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61. |
| Name | Type | Description |
|---|---|---|
| Sa-5Ag half dose non-adjuvanted | BIOLOGICAL | 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly. |
| Sa-5Ag full dose non-adjuvanted | BIOLOGICAL | 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly. |
| Sa-5Ag half dose adjuvanted | BIOLOGICAL | 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly. |
| Sa-5Ag full dose adjuvanted | BIOLOGICAL | A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly. |
| Placebo | BIOLOGICAL | One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo Groups 1 to 3 (Dose-escalation epoch) and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo Group 4 (Dose-escalation epoch) and Group PoP: Placebo, administered intramuscularly. |
Inclusion Criteria: All participants must satisfy all the following criteria at study entry: * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written or witnessed i...
Sa-5Ag half dose non-adjuvanted is an investigational vaccine being studied for the prevention of Staphylococcus aureus skin and soft tissue infections. It is being evaluated in adults 18 to 64 years of age who have had a recent S. aureus skin and soft tissue infection, as well as in healthy adults.
Sa-5Ag half dose non-adjuvanted is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this candidate vaccine for infectious disease indications.
Sa-5Ag half dose non-adjuvanted is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine remains under clinical investigation.
Sa-5Ag half dose non-adjuvanted was studied in a completed Phase 2 trial with the identifier NCT04420221. This randomized, double-blind, placebo-controlled trial enrolled 226 participants to evaluate the safety, immunogenicity, and efficacy of the vaccine candidate in healthy adults and in adults with recent S. aureus skin and soft tissue infections.
Yes, Sa-5Ag half dose non-adjuvanted is the same as GSK3878858A. The clinical trial NCT04420221 refers to the candidate as GSK S. aureus Candidate Vaccine (GSK3878858A), and the half dose non-adjuvanted formulation is one of the versions being tested.