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PED-HZ/su

Phase 1

Herpes Zoster | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Feb 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment184
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04006808A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney TransplantPHASE1 RECRUITING 184Oct 25, 2019Mar 31, 2027Feb 27, 202631 Belgium, France +4
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Study Endpoints
Primary Endpoints
Number of subjects from the interventional groups, with solicited local adverse events (AEs)
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)

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.

Number of subjects from the interventional groups, with solicited general AEs
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)

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.

Number of subjects from the control groups with solicited general symptoms
Within 7 days after Visit Day 1

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.

Number of subjects from the interventional groups with unsolicited AEs after each vaccination
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)

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.

Number of subjects from the control groups with unsolicited symptoms
Within 30 days after Visit Day 1

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.

Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection.
From Visit Day 1 up to Visit Month 2

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).

Number of subjects from the interventional groups with seizures
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)

All seizures occurring within 30 days following study vaccination are reported.

Number of subjects from the non-interventional groups with seizures
Within 30 days after Visit Day 1

All seizures occurring within 30 days after visit day 1 are reported, for the control groups.

Number of subjects from the interventional groups with generalized convulsive seizures
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)

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.

Number of subjects from the non-interventional groups with generalized convulsive seizures
Within 7 days after Visit Day 1

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

Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
At Month 2 (one-month post-dose 2)

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

Secondary Endpoints
Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13
From Visit Day 1 up to Visit Month 13
Occurrence of Herpes Zoster cases
From Visit Day 1 until Visit Month 13
Number of subjects from the interventional pooled age group with solicited local AEs
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PED-HZ/su 12-17 GroupEXPERIMENTALPaediatric renal transplant recipients aged 12 to 17 years old, receiving 2 doses of the investigational vaccine (PED HZ/su)
Control 12-17 GroupNO_INTERVENTIONPaediatric 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 GroupEXPERIMENTALPaediatric 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 GroupNO_INTERVENTIONPaediatric renal transplant recipients aged 1 to 11 years old, not receiving the investigational vaccine but being treated according to the local standard of care
Interventions
NameTypeDescription
PED-HZ/suBIOLOGICALGSK'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.
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Eligibility Criteria
Age Range1 Year — 17 Years
SexALL
Healthy VolunteersNo
Study Sites31

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...

Countries:BelgiumFranceItalyPolandSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04006808primaryCompletionDate: changed
LOWMay 24, 2026NCT04006808studyFirstPostDate: changed