Herpes ZosterPhase 1/2NCT04006808
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
A Phase 1/2 study testing PED-HZ/su in people with Herpes Zoster, run by GlaxoSmithKline at 31 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant recipients aged 1-17 years Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- PED-HZ/su
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 31 sitesin 6 countries
- Study dates
- 25 Oct 2019to 31 Mar 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 to performance of any study specific procedure.
- Written informed assent obtained from the subjects when applicable according to local requirements.
- A male or female between, and including, 1 and 17 years of age at the time of randomisation (Visit Day 1)
- Body weight ≥ 6 kg/13.23 pounds.
- A subject is eligible if they meet at least one of the following criteria:
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- Documented previous VZV vaccination OR
- Medically verified varicella (with source documentation) OR
- Seropositive for VZV prior to transplantation.
- Subjects with renal transplant more than six months (180 days) prior randomization (Visit Day 1)
- Subject who has received an ABO compatible allogeneic renal transplant (allograft).
- Subject with stable renal function with stability defined as <20% variability between the last two creatinine measurements or based on investigator opinion after review of multiple creatinine measurements.
- Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to randomization (Visit Day 1).
- Female subjects of childbearing potential may be enrolled in the study, if the subject
- has practiced adequate contraception for 30 days prior to Visit Day 1 and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
Who cannot join
- Medical conditions
- Any primary kidney disease with a high incidence of recurrent primary kidney disease within the allograft
- Evidence of recurrent primary kidney disease within the current allograft
- Previous allograft loss secondary to recurrent primary kidney disease
- History of more than one organ transplanted (that is, kidney-liver, simultaneous double kidney or kidney-other organ(s) transplanted).
- Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment
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- Panel Reactive Antibodies (PRA) calculated PRA (cPRA) or Calculated Reaction Frequency (cRF) score that is unknown at the time of transplant
- VZV serostatus unknown prior to transplant
- Subjects with advanced chronic kidney disease
- Evidence of significant proteinuria (≥ 200 g/mol creatinine) believed to be of renal origin (an example of non-renal origin is proteinuria from mucus in a reconstructed bladder)
- Subjects without multiple dialysis options in the event acute or chronic dialysis needed.
- History of unstable or progressive neurological disorder.
- Subjects ≤ 5 years of age with a history of one or more simple or complex febrile seizures
- Subjects > 5 years with history of one or more complex febrile seizures
- Occurrence of a varicella or HZ episode by clinical history within the 6 months (180 days) preceding Visit Day 1
- Any autoimmune disease, with the following exceptions which do not constitute an exclusion criterion:
- IgA nephropathy
- Rapidly progressive glomerulonephritis
- Membranous glomerulonephritis
- Idiopathic Type I membranoproliferative glomerulonephritis
- Diabetes mellitus (type 1 and 2) with diabetic nephropathy
- Confirmed or suspected Human Immunodeficiency Virus or primary immunodeficiency disease
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
- Any condition which, in the judgement of the investigator would make intramuscular injection unsafe.
- Atypical Haemolytic Uraemic Syndrome.
- Prior/Concomitant therapy
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before Visit Day 1 (Day -29 to Day -1), or planned use during the study period.
- Subject in receipt of treatment for rejection during the six months (180 days) prior to enrolment.
- Use of anti-CD20 or other B-cell monoclonal antibody agents within 1 year of Visit Day 1 or planned administration during the duration of the study.
- Administration of blood products 3 months (90 days) prior to Visit Day 1 or planned administration during the duration of the study.
- Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or planned administration of immunoglobulins during the duration of the study.
- Administration or planned administration of a vaccine within 30 days prior to Visit Day 1 up to Visit Month 2 with the exception of an inactivated or subunit influenza vaccine which may be given 8 days prior to or 14 days after Visit Day 1 and 8 days prior to or 14 days after Visit Month 1.
- Previous vaccination against HZ
- Varicella vaccination within the 6 months (180 days) preceding Visit Day 1
- Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine
- Prior/Concurrent clinical study experience
- Concurrent or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- available locally through compassionate use programs,
- submitted for and pending local/country registration,
- approved and registered for use in other countries with well-documented Summary of Product Characteristics or Prescribing Information
- The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing
- Other exclusions
- Child in care
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) between one month (30 days) prior to Visit Day 1 through two months (60 days) after Visit Month 1.
- Evidence or high suspicion, in the opinion of the investigator, of non-compliance or non-adherence to use of induction and/or maintenance immunosuppressive therapies.
- Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit
- Completion must cover the 7 days immediately prior to randomisation (Visit Day 1).
- Completion is defined as a minimum of 6 days completed.
- Subjects with less than 6 days completed may be offered a new date for Visit Day 1 and the opportunity to comply with the completion of the 7-day pre-vaccination diary card prior to the new planned Visit Day 1.
- Any study personnel or their immediate dependants, family, or household member.
Trial locations and contacts
31 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 6 countries
France8 sites, 7 recruiting
- Recruiting
GSK Investigational Site
Bordeaux, 33000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Lille, 59000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Marseille, 13385
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Montpellier, 34295
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Withdrawn
GSK Investigational Site
Nantes, 44093
- Recruiting
GSK Investigational Site
Paris, 75015
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Paris, 75019
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toulouse, 31059
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom7 sites, 5 recruiting
- Completed
GSK Investigational Site
Birmingham, B4 6NH
- Completed
GSK Investigational Site
Cardiff, CF14 4XW
- Recruiting
GSK Investigational Site
Glasgow Strathclyde, G51 4TF
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
London, WC1N 3JH
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Manchester, M13 9WL
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nottingham, NG7 2UH
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Southampton, SO16 6YD
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Spain6 sites, 5 recruiting
- Recruiting
GSK Investigational Site
BaracaldoVizcaya, 48903
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Espluges de Llobregat, 08950
- Recruiting
GSK Investigational Site
HebrOn, 08035
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28046
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seville, 41013
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Italy5 sites, 4 recruiting
- Completed
GSK Investigational Site
Genova, 16147
- Recruiting
GSK Investigational Site
Milan, 20122
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Padova, 35128
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Roma, 00165
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Torino, 10126
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Belgium4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Brussels, 1020
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ghent, 9000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Leuven, 3000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Liège, 4000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Poland1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Gdansk, 80-952
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Reactogenicity, Safety and Immunogenicity Study of GSK's Paediatric Herpes Zoster Subunit Candidate Vaccine (PED-HZ/su) GSK143713A in Immunocompromised Paediatric Renal Transplant Recipients
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant recipients aged 1-17 years
- Conditions
- Herpes Zoster
- Being tested
- PED-HZ/su
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PED-HZ/suBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: 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. Receives: Biological: PED-HZ/su |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects from the interventional groups, with solicited local adverse events (AEs)
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.
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the interventional groups, with solicited general AEs
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.
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the control groups with solicited general symptoms
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.
Measured: Within 7 days after Visit Day 1
Number of subjects from the control groups with solicited general symptoms
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
Measured: Within 7 days after Visit Month 1
Number of subjects from the interventional groups with unsolicited AEs after each vaccination
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.
Measured: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the control groups with unsolicited symptoms
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.
Measured: Within 30 days after Visit Day 1
Number of subjects from the control groups with unsolicited symptoms
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.
Measured: Within 30 days after Visit Month 1
Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection.
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).
Measured: From Visit Day 1 up to Visit Month 2
Number of subjects from the interventional groups with seizures
All seizures occurring within 30 days following study vaccination are reported.
Measured: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional groups with seizures
All seizures occurring within 30 days after visit day 1 are reported, for the control groups.
Measured: Within 30 days after Visit Day 1
Number of subjects from the non-interventional groups with seizures
All seizures occurring within 30 days of visit month 1 are reported, for the control groups
Measured: Within 30 days after Visit Month 1
Number of subjects from the interventional groups with generalized convulsive seizures
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.
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional groups with generalized convulsive seizures
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
Measured: Within 7 days after Visit Day 1
Number of subjects from the non-interventional groups with generalized convulsive seizures
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
Measured: Within 7 days after Visit Month 1
Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
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
Measured: At Month 2 (one-month post-dose 2)
Secondary outcomes (21)
Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13
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.
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Measured: From Visit Day 1 up to Visit Month 13
Occurrence of Herpes Zoster cases
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Measured: From Visit Day 1 until Visit Month 13
Number of subjects from the interventional pooled age group with solicited local AEs
The pooled age group includes all subjects aged 1-17 years.
The assessed local AEs solicited are:
- Pain
- Redness
- Swelling Note: Pain includes tenderness.
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the interventional pooled age group with solicited general AEs
The pooled age group includes all subjects aged 1-17 years.
The assessed solicited general AEs among Infants/Toddlers/Children < 6 years are:
- Drowsiness
- Fever*
- Irritability/Fussiness
- Loss of appetite
- Gastrointestinal (GI) symptoms**
The 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
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional pooled age group with solicited general symptoms
The pooled age group includes all subjects aged 1-17 years.
The assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are:
- Drowsiness
- Fever*
- Irritability/Fussiness
- Loss of appetite
- GI symptoms**
The 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.
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the interventional pooled age group with unsolicited AEs after each vaccination
The pooled age group includes all subjects aged 1-17 years. 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.
Measured: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
The pooled age group includes all subjects aged 1-17 years. 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.
Measured: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
The pooled age group includes all subjects aged 1-17 years. 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.
Measured: Within 30 days after Visit Month 1
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
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.
Measured: From Visit Day 1 until Visit Month 2
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
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.
Measured: From Visit Day 1 until Visit Month 13
Number of subjects from the pooled age groups with HZ
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella.
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Measured: From Visit Day 1 until Visit Month 13
Number of subjects from the interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring within 30 days following study vaccination are reported
Measured: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit day 1 are reported
Measured: Within 30 days after Visit Day 1
Number of subjects from the non-interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit month 1 are reported
Measured: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years.
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
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years.
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
Measured: Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years.
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
Measured: Within 7 days after Visit Month 1
Vaccine Response Rate (VRR) for Anti-glycoprotein (Anti-gE) antibody concentrations
The Vaccine Response Rate for anti-gE antibodies is defined as the percentage of subjects who have at least:
- a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline, or,
- a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline.
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Measured: At Month 2 and Month 13
Median fold increase of anti-gE antibody concentrations
Median fold increase in antibody concentration with 95% Confidence Interval is tabulated for the interventional groups by age strata (1-11 years and 12-17 years) This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Measured: At Month 2 and Month 13
Percentage of subjects with anti-gE antibody concentrations in terms of GMCs
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
Measured: At Day 1 (pre-vaccination) and Month 13
Percentage of subjects in the interventional pooled age group, with Anti-gE antibody concentrations in terms of GMCs
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.
Median fold increase in antibody concentration with 95% Confidence Interval is to be tabulated for the interventional groups by pooled age category (1-17 years).
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Measured: At Day 1, Month 2 and Month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start25 Oct 2019
- Primary completion1 May 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006808
- Sponsor's protocol ID
- 200075
- Other IDs
- 2019-000607-33, 2019
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2019
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Mollo A, Peri M, Lodi L, Gissi A, Lionetti P, Marrani E, Mastrolia MV, Tondo A, Tintori V, Sardi I, Indolfi G, Trapani S, Galli L, Venturini E, Astorino V, Azzari C, Ricci S. Considering recombinant herpes zoster vaccine for fragile pediatric patients: A new opportunity. Vaccine. 2025 Apr 19;53:127072. doi: 10.1016/j.vaccine.2025.127072. Epub 2025 Apr 7.
PubMed 40198934