Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK 1437173A · 1 trial · 2 indications
Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.
Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
The number of days with any local symptoms has been assessed during the post-vaccination period.
Assessed solicited general symptoms were fatigue, gastrointestinal \[symptoms included nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and fever \[defined as oral, axillary or tympanic temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
The number of days with any general symptoms has been assessed during the post-vaccination period.
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 any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE= SAE assessed by the investigator as causally related to the study vaccination.
Potential immune-mediated diseases (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 aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.
| Arm | Type | Description |
|---|---|---|
| GSK1437173A Group | EXPERIMENTAL | Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients. |
| Name | Type | Description |
|---|---|---|
| GSK 1437173A | BIOLOGICAL | 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm. |
| Placebo | DRUG | 2 doses administered by IM injection into the deltoid muscle of the non-dominant arm. |
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. * A male or female aged 18 years or older (and has reached the age of legal consent) at the time of study entry (i...
GSK 1437173A is an investigational monoclonal antibody being studied for the prevention of Herpes Zoster, also known as shingles. It is being developed by GSK plc for use in adults with solid tumors who are receiving chemotherapy, a population at increased risk for this viral infection.
GSK 1437173A is developed by GSK plc, a global biopharma company traded on the London Stock Exchange under the ticker GSK. The company is conducting clinical research to evaluate the safety and immunogenicity of this monoclonal antibody in patients with solid tumors undergoing chemotherapy.
GSK 1437173A is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation for its potential use in preventing Herpes Zoster in immunocompromised patients.
GSK 1437173A has one completed Phase 3 clinical trial registered as NCT01798056. This randomized, double-blind, placebo-controlled study enrolled 237 adults with solid tumors receiving chemotherapy to assess the immunogenicity and safety of the drug for Herpes Zoster prevention.
GSK 1437173A is a monoclonal antibody, a type of biologic drug designed to target a specific protein involved in the immune response. As a monoclonal antibody, it is intended to provide passive immunity against the varicella-zoster virus, which causes Herpes Zoster, though the exact molecular target is not specified.