Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00920218 | Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A | PHASE2 | COMPLETED | 121 | — | — | Jul 14, 2009 | Mar 21, 2012 | Dec 12, 2017 | 11 | United States |
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 activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[including nausea, vomiting, diarrhoea and abdominal pain\], temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
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.
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.
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \[IFN-γ\], Interleukin 2 \[IL-2\], Tumour Necrosis Factor alpha \[TNF-α\] and/or CD40 Ligand \[CD40L\] as determined by in vitro intracellular cytokine staining (ICS).
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
| Arm | Type | Description |
|---|---|---|
| GSK 1437173A F1 Group | EXPERIMENTAL | Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule. |
| GSK 1437173A F2 Group | EXPERIMENTAL | Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule. |
| Placebo-GSK 1437173A F1 Group | EXPERIMENTAL | Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule. |
| Placebo Group | PLACEBO_COMPARATOR | Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule. |
| Name | Type | Description |
|---|---|---|
| Herpes Zoster Vaccine 1437173A | BIOLOGICAL | Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly. |
| Placebo vaccine (saline) | BIOLOGICAL | 1 or 3 doses of Placebo (saline) injected intramuscularly. |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol; * Male and female subjects at least 18 years old at the time of vaccination; * Serological evidence of prior VZV infection for all subjects born in 1980 or later and for...