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MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS

Clinical trials are studying MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS in children and adolescents. These studies look at immune response, safety, and how well measles-containing vaccines work in different groups, including healthy toddlers and children after cancer treatment.

Table of contents

Trial overview

Two authorised Phase 3 clinical trials are studying MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS in different patient groups.[1][2] One trial focuses on children and adolescents after childhood cancer treatment, and the other focuses on healthy children 12 to 15 months old.[1][2]

These studies are not testing the substance as a stand-alone treatment. They are looking at vaccine response, protection, and safety in real-life groups who need measles-containing vaccination or varicella vaccination.[1][2]

Study populations and conditions

The first trial includes children and adolescents from 0 to 18 years old with pediatric cancer.[1] Its main goal is to examine immunity after revaccination against measles and chickenpox after treatment for childhood cancer.[1]

The second trial includes healthy children 12 to 15 months of age and studies varicella, which is the medical name for chickenpox.[2] This study also includes a marketed measles, mumps and rubella vaccine and compares different ways of giving the vaccines.[2]

In the trial summaries, the vaccine names include MEASLES, COMBINATIONS WITH MUMPS AND RUBELLA, LIVE ATTENUATED and VARICELLA, LIVE ATTENUATED, along with a study vaccine listed as GSKVX000000025896.[1][2]

Main outcomes and endpoints

The first trial measures the difference in VZ IgG antibody levels before and after revaccination against chickenpox, and the difference in measles IgG antibody levels before and after revaccination against measles.[1] In simple terms, it checks whether antibody protection improves after the vaccines are given again.[1]

The trial summary also states that the researchers will look at the proportion of patients with a protective VZ-IgG level after vaccination compared with before vaccination, and the proportion with a protective morbilli-IgG level after vaccination compared with before vaccination.[1] Morbilli is another name used for measles in the study text.[1]

The second trial measures seroresponse to VZV gE and to MMR antigens at Day 43, plus anti-VZV gE IgG concentration and anti-measles, anti-mumps, and anti-rubella IgG concentrations at Day 43.[2] These are blood test measures that show whether the immune system responded after vaccination.[2]

This second study has a non-inferiority goal, which means it is checking whether intramuscular vaccination is not worse than subcutaneous vaccination by more than an allowed amount.[2] It compares intramuscular administration with subcutaneous administration for both the varicella vaccine and the MMR vaccine.[2]

Trial design, phase, and status

Both studies are interventional, which means researchers actively give the vaccine and then measure the results.[1][2] Both are also marked Authorised in the source data.[1][2]

The first trial has an enrollment of 160 participants.[1] The second trial has a larger enrollment of 944 participants.[2] Larger enrollment can help researchers compare immune responses more reliably across groups.[2]

The first trial is focused on revaccination after childhood cancer treatment, while the second trial is focused on vaccination in young healthy children and on comparing injection routes.[1][2] Together, they show how the same vaccine-related research topic can be studied in different populations and for different practical questions.[1][2]

What the study results mean for patients

For families, the key question in these trials is whether vaccination leads to enough antibody protection after cancer treatment or in early childhood.[1][2] The studies use blood tests to see if the immune system has responded in a measurable way.[1][2]

The first study is especially relevant for children and teenagers who may need protection again after cancer therapy.[1] The second study is especially relevant for healthy toddlers who are receiving routine vaccine protection and for understanding whether two injection methods give similar immune results.[2]

Overall, the trial data focus on immune response, protection levels, age group, and how the vaccine is given, rather than on long-term disease outcomes.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-511182-10-01 Phase 3 Pediatric cancer Authorised 160
NCT06855160 Phase 3 Varicella Authorised 944

FAQ

  • Who can take part in these trials? The trials include healthy children 12 to 15 months old and children and adolescents 0 to 18 years old who have had childhood cancer. Each study has its own entry rules.
  • What are the trials trying to find out? The studies are checking whether vaccination leads to a good immune response and whether it is safe. One trial also compares intramuscular and subcutaneous injection methods.
  • What phases are these studies? Both trials are Phase 3 studies. Phase 3 trials usually test how well a vaccine or treatment works in larger groups of people.
  • What conditions are being studied? One trial is in pediatric cancer, focusing on revaccination after cancer treatment. The other trial is in varicella, which is chickenpox, in healthy young children.
  • What outcomes are measured? The trials measure antibody levels and seroresponse, which means whether the body makes a measurable immune response after vaccination. They also look at immune protection before and after revaccination.

Ongoing Clinical Trials on MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS

  • Study of new chickenpox vaccine and measles-mumps-rubella vaccine given by intramuscular injection in healthy children aged 12 to 15 months

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Denmark Estonia Greece Lithuania +2

  • Study on Immunity to Measles and Chickenpox in Children with Cancer Using Measles, Mumps, Rubella, and Varicella Vaccines

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

Glossary

  • Phase 3: A later stage of clinical research that studies how well a vaccine or treatment works and continues to watch safety in a larger group of people.
  • Interventional study: A study where researchers give a vaccine or treatment and then measure the results.
  • Immune response: How the body reacts to a vaccine by making protection against a disease.
  • Antibody: A protein made by the immune system that helps protect the body from infection.
  • IgG: A type of antibody often measured in blood tests to see if a person has protection against an infection.
  • Seroresponse: A measurable change in blood antibodies after vaccination, showing the body has responded.
  • Revaccination: Giving a vaccine again to improve or restore protection.
  • Varicella: The medical name for chickenpox.
  • Measles, mumps, and rubella vaccine: A combined vaccine that protects against three viral diseases: measles, mumps, and rubella.
  • Intramuscular injection: A shot given into a muscle.
  • Subcutaneous injection: A shot given under the skin.
  • Non-inferiority: A study goal that checks whether one approach is not worse than another by more than a set amount.

References