Table of contents
- Overview of the trial
- Who the trial is for
- Study design and phase
- What the trial measures
- Vaccine context in the study
- Why this research matters
Overview of the trial
This clinical trial studies VARICELLA VIRUS OKA STRAIN (LIVE, ATTENUATED) in children and adolescents after treatment for childhood cancer.[1] It is an interventional study, which means the researchers give a vaccine and then measure the results.[1]
The trial is authorised and is listed as Phase 3.[1] The planned enrollment is 160 participants.[1]
Who the trial is for
The target population is children and adolescents from 0 to 18 years old with pediatric cancer.[1] The study focuses on people after cancer treatment, when the medical team wants to check whether vaccine protection has returned or improved.[1]
Study design and phase
This is a Phase 3 trial.[1] Phase 3 studies usually look at how well a treatment or vaccine works in a larger group of patients.[1]
The study is interventional, so participants receive vaccine injections and the researchers compare blood test results before and after revaccination.[1] The intervention list includes a live attenuated measles, mumps, and rubella vaccine and a live attenuated varicella vaccine, both given by intramuscular injection.[1]
What the trial measures
The main endpoint for the varicella part of the study is the difference in VZ IgG antibody levels before and after revaccination against chickenpox.[1] For the measles part, the main endpoint is the difference in measles IgG antibody levels before and after revaccination.[1]
These blood tests help show whether the body has a stronger immune response after vaccination.[1] In the brief summary, the study also describes the proportion of patients with a protective VZ-IgG level after vaccination compared with before vaccination, and the same type of comparison for morbilli IgG, which is another word used for measles in the source data.[1]
Vaccine context in the study
The source data names the chickenpox vaccine as VARICELLA, LIVE ATTENUATED and the measles-containing vaccine as MEASLES, COMBINATIONS WITH MUMPS AND RUBELLA, LIVE ATTENUATED.[1] The trial does not describe the vaccines as a treatment for cancer; instead, it uses them to study immune response after cancer therapy.[1]
Why this research matters
Children and adolescents after cancer treatment may need their protection against common infections checked again.[1] This study helps researchers see whether revaccination can improve measurable immunity against chickenpox, and also against measles in the same patient group.[1]
