Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PED-HZ/su · 1 trial · 1 indication
Assessed solicited local AEs are pain, redness and swelling at the injection site. Pain includes tenderness. Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects \< 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Assessed solicited general AEs among Infants/Toddlers/Children \< 6 years are: * Drowsiness * Fever\* * Irritability/Fussiness * Loss of appetite * Gastrointestinal (GI) symptoms\*\* Assessed solicited general AEs among Children ≥ 6 years are: * Fatigue * Fever\* * GI symptoms\*\* * Headache * Myalgia * Shivering (chills) * Fever is defined as temperature ≥ 38.0°C/100.4°F \*\*GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects \< 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Assessed solicited general symptoms among Infants/Toddlers/Children \< 6 years are: * Drowsiness * Fever\* * Irritability/Fussiness * Loss of appetite * GI symptoms\*\* Assessed solicited general symptoms among Children ≥ 6 years are: * Fatigue * Fever\* * GI symptoms\*\* * Headache * Myalgia * Shivering (chills) * Fever is defined as temperature ≥ 38.0°C/100.4°F \*\*GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain As subjects from the control group are not vaccinated, they will not complete the diary card for local solicited symptoms.
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 is to be reported as an unsolicited adverse event.
An unsolicited symptom is any symptom 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 is to be reported as an unsolicited adverse event.
An 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 sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury. The reporting period for any renal allograft rejection is from Visit Day 1 to the study end (month 2).
All seizures occurring within 30 days following study vaccination are reported.
All seizures occurring within 30 days after visit day 1 are reported, for the control groups.
Generalized convulsive seizures are classified as follows: * Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations * Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations * Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations * Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above * Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure.
Generalized convulsive seizures are classified as follows: * Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations * Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations * Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations * Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above * Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
The geometric mean concentration (GMC) calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation
| Arm | Type | Description |
|---|---|---|
| PED-HZ/su 12-17 Group | EXPERIMENTAL | Paediatric renal transplant recipients aged 12 to 17 years old, receiving 2 doses of the investigational vaccine (PED HZ/su) |
| Control 12-17 Group | NO_INTERVENTION | Paediatric renal transplant recipients aged 12 to 17 years old, not receiving the investigational vaccine but being treated according to the local standard of care |
| PED-HZ/su 1-11 Group | EXPERIMENTAL | Paediatric renal transplant recipients aged 1 to 11 years old, receiving 2 doses of the investigational vaccine (PED HZ/su). Enrolment into this group will be in a staggered manner. Following enrolment into the PED-HZ/su 12-17 group, a safety evaluation of data collected up to visit month 2 will be performed. Upon favourable outcome of the evaluation, enrolment into this group will begin. |
| Control 1-11 Group | NO_INTERVENTION | Paediatric renal transplant recipients aged 1 to 11 years old, not receiving the investigational vaccine but being treated according to the local standard of care |
| Name | Type | Description |
|---|---|---|
| PED-HZ/su | BIOLOGICAL | GSK's candidate vaccine- PED-HZ/su. is administered intramuscularly in the deltoid of the non-dominant arm, on a two-dose schedule in the two investigational groups. |
Inclusion Criteria: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol * Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior t...
PED-HZ/su is an investigational monoclonal antibody being developed for the prevention of Herpes Zoster, commonly known as shingles. It is specifically being studied in children with kidney transplant, a population at increased risk for this condition. The drug is currently in Phase 1 clinical development and is not yet approved.
PED-HZ/su is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for the prevention of shingles in pediatric kidney transplant recipients.
PED-HZ/su is currently in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and immunogenicity of the drug in children with kidney transplant. The drug is investigational and has not yet received regulatory approval for any indication.
PED-HZ/su is being evaluated in a single Phase 1 clinical trial with the identifier NCT04006808. This study, titled 'A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant,' is currently recruiting participants and aims to enroll 184 children aged 1 year and older.
Yes, PED-HZ/su is also known as GSK1437173A. The clinical trial NCT04006808 refers to the drug as GSK1437173A, which is the candidate vaccine name used by GSK. Both names refer to the same investigational monoclonal antibody being studied for the prevention of shingles in children with kidney transplant.
PED-HZ/su is a monoclonal antibody, a type of biologic drug designed to target a specific molecule involved in the disease process. However, the specific molecular target of PED-HZ/su has not been disclosed in the available information. The drug is being studied for its ability to prevent Herpes Zoster in a vulnerable pediatric population.