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New shingles vaccine trial aims to protect vulnerable kids

NCT ID NCT04006808

Vaccine Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new shingles vaccine (PED-HZ/su) in children aged 1 to 17 who have had a kidney transplant and have weakened immune systems. The vaccine is given as two shots in the arm. Researchers are checking how safe it is, what side effects occur, and how well it boosts the body's defenses against the shingles virus. The trial involves 184 participants and is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PED-HZ/su (shingles vaccine candidate)
What this could lead to
If it works, this could provide a safe way to prevent shingles in children with weakened immune systems after a kidney transplant.
What could go wrong
This is an early (Phase 1/2) study with only 184 participants, so results may not apply to all. The vaccine could cause side effects like pain, fever, or rarely, more serious issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 184 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: * 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 Exclusion Criteria: 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 * 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.

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Conditions

The condition(s) this trial relates to.

herpes zoster prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Herpes zoster

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Brussels, 1020, Belgium

  • GSK Investigational Site

    RECRUITING

    Ghent, 9000, Belgium

  • GSK Investigational Site

    RECRUITING

    Leuven, 3000, Belgium

  • GSK Investigational Site

    RECRUITING

    Liège, 4000, Belgium

  • GSK Investigational Site

    RECRUITING

    Bordeaux, 33000, France

  • GSK Investigational Site

    RECRUITING

    Lille, 59000, France

  • GSK Investigational Site

    RECRUITING

    Marseille, 13385, France

  • GSK Investigational Site

    RECRUITING

    Montpellier, 34295, France

  • GSK Investigational Site

    WITHDRAWN

    Nantes, 44093, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75015, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75019, France

  • GSK Investigational Site

    RECRUITING

    Toulouse, 31059, France

  • GSK Investigational Site

    COMPLETED

    Genova, 16147, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20122, Italy

  • GSK Investigational Site

    RECRUITING

    Padova, 35128, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00165, Italy

  • GSK Investigational Site

    RECRUITING

    Torino, 10126, Italy

  • GSK Investigational Site

    RECRUITING

    Gdansk, 80-952, Poland

  • GSK Investigational Site

    RECRUITING

    BaracaldoVizcaya, 48903, Spain

  • GSK Investigational Site

    COMPLETED

    Espluges de Llobregat, 08950, Spain

  • GSK Investigational Site

    RECRUITING

    HebrOn, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28046, Spain

  • GSK Investigational Site

    RECRUITING

    Seville, 41013, Spain

  • GSK Investigational Site

    COMPLETED

    Birmingham, B4 6NH, United Kingdom

  • GSK Investigational Site

    COMPLETED

    Cardiff, CF14 4XW, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Glasgow Strathclyde, G51 4TF, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

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