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
Age range
1 Year – 17 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of subjects from the interventional groups, with solicited local adverse events (AEs)
Timeframe: 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
Timeframe: 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
Timeframe: Within 7 days after Visit Day 1
Number of subjects from the control groups with solicited general symptoms
Timeframe: Within 7 days after Visit Month 1
Number of subjects from the interventional groups with unsolicited AEs after each vaccination
Timeframe: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the control groups with unsolicited symptoms
Timeframe: Within 30 days after Visit Day 1
Number of subjects from the control groups with unsolicited symptoms
Timeframe: 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.
Timeframe: From Visit Day 1 up to Visit Month 2
Number of subjects from the interventional groups with seizures
Timeframe: Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Number of subjects from the non-interventional groups with seizures
Timeframe: Within 30 days after Visit Day 1
Number of subjects from the non-interventional groups with seizures
Timeframe: Within 30 days after Visit Month 1
Number of subjects from the interventional groups with generalized convulsive seizures
Timeframe: 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
Timeframe: Within 7 days after Visit Day 1
Number of subjects from the non-interventional groups with generalized convulsive seizures
Timeframe: Within 7 days after Visit Month 1
Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
Timeframe: At Month 2 (one-month post-dose 2)