Europas førende søgning efter kliniske forsøg

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

Clinical trials of MEASLES VIRUS EDMONSTON-SCHWARZ STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS are studying vaccination responses in children and adolescents, including those with childhood cancer and healthy young children. The trials look at immune response, safety, and whether different ways of giving vaccines work as well as standard methods.

Table of contents

Overview of the clinical trials

The trial data describe two interventional studies, which means researchers give vaccines and then measure the results.[1][2] Both studies are listed as Phase 3 and are marked Authorised.[1][2] The studies look at immune response to measles and chickenpox vaccination in different pediatric groups.[1][2]

Who is being studied

One study includes children and adolescents aged 0 to 18 years with childhood cancer.[1] The other study includes healthy children aged 12 to 15 months.[2] These groups are studied separately because the vaccine questions are different in each setting.[1][2]

How the studies are designed

The first trial is described as a clinical phase IV trial in the title, but the trial record lists Phase 3.[1] It examines revaccination after treatment for childhood cancer.[1] The second trial compares intramuscular injection with subcutaneous injection for vaccine delivery.[2]

In the first trial, the interventions include MEASLES, COMBINATIONS WITH MUMPS AND RUBELLA, LIVE ATTENUATED and VARICELLA, LIVE ATTENUATED.[1] In the second trial, the study includes an investigational chickenpox vaccine and a marketed measles, mumps and rubella vaccine.[2] The trial record also names products such as Priorix, VARIVAX, and GSKVX000000025896 in the intervention list.[2]

What the trials measure

The main outcomes are about antibody levels, which show how the immune system responds after vaccination.[1][2] One trial measures the difference in VZ IgG and measles IgG before and after revaccination.[1] The other trial measures seroresponse and IgG concentration at Day 43 after vaccination.[2]

The first study focuses on whether revaccination increases protective antibody levels against chickenpox and measles after childhood cancer treatment.[1] The second study checks whether the intramuscular route is non-inferior, meaning not worse than the standard route by a clinically important amount, for immune response to varicella and MMR vaccines.[2]

Trial in children and adolescents with childhood cancer

This study is titled as a phase IV trial, but the record lists Phase 3 and includes 160 participants.[1] It studies children and adolescents aged 0 to 18 years who have had childhood cancer treatment.[1] The goal is to examine cellular and humoral immunity against measles and chickenpox after revaccination.[1]

The primary outcomes are the change in VZ IgG antibody levels before and after revaccination against chickenpox, and the change in measles IgG antibody levels before and after revaccination against measles.[1] The brief summary says the study looks at the proportion of patients with protective antibody levels before and after vaccination.[1]

Trial in healthy young children

This study includes 944 healthy children aged 12 to 15 months and is listed as Phase 3.[2] It studies the immune response and safety of an investigational chickenpox vaccine together with a marketed measles, mumps and rubella vaccine.[2] The study compares intramuscular administration with subcutaneous administration.[2]

The main endpoints are seroresponse to VZV gE at Day 43, anti-VZV gE IgG concentration at Day 43, seroresponse to MMR antigens at Day 43, and anti-measles, anti-mumps, and anti-rubella IgG concentration at Day 43.[2] The study aims to show non-inferiority for both vaccine types when given intramuscularly compared with subcutaneously.[2]

Key points for patients

These trials are not about treating an active measles infection; they are about vaccination response in children.[1][2] The main question is whether the body makes enough protective antibodies after vaccination or revaccination.[1][2] The studies also help researchers compare different vaccine products and different ways of giving the injection.[2]

For the childhood cancer study, the focus is on recovery of immunity after cancer treatment.[1] For the infant study, the focus is on whether a new or investigational chickenpox vaccine works as well as standard vaccination methods when given by muscle injection.[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 is being studied in these trials? The trials include children and adolescents aged 0 to 18 years with childhood cancer, and healthy children aged 12 to 15 months. These are different groups with different vaccine questions.
  • What is being studied in the trial data? The studies look at immune response and safety after vaccination. One trial measures antibody levels after revaccination, and another compares intramuscular and subcutaneous vaccination methods.
  • What conditions are covered by these trials? The trial data covers pediatric cancer and varicella, which is chickenpox. Measles vaccine response is also studied in both trials.
  • What phases are the trials in? Both trials are Phase 3 studies. One is described as a clinical phase IV trial in the title, but the trial record lists Phase 3.
  • What outcomes are measured? The studies measure antibody changes before and after vaccination, including IgG levels and seroresponse. One trial also measures results at Day 43 after vaccination.

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

  • Undersøgelse af immunrespons og sikkerhed ved intramuskulær injektion af en eksperimentel skoldkoppevaccine og mæslinger-fåresyge-røde hunde-vaccine hos raske børn i alderen 12-15 måneder

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien Bulgarien Danmark Estland Grækenland Litauen +2

  • Undersøgelse af effekten af vaccine mod skoldkopper og mæslinger hos børn og unge, der har været behandlet for kræft

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Sverige

Ordliste

  • Phase 3: A later stage of clinical research that checks how well a vaccine or treatment works and continues to monitor safety in larger groups.
  • Phase IV: A study done after a product is already in use, often to learn more about real-world effects. In the trial data, one study is called phase IV in the title.
  • 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.
  • Humoral immunity: Protection made by antibodies in the blood and body fluids.
  • Cellular immunity: Protection made by immune cells that help fight infection.
  • IgG antibody: A type of antibody often used to check whether a person has protection after vaccination.
  • Seroresponse: A rise in blood antibody levels after vaccination, showing that the immune system responded.
  • GMC: Geometric mean concentration, a way to show the average antibody level in a group.
  • Revaccination: Giving a vaccine again after a person has already been vaccinated before.
  • Intramuscular injection: An injection given into a muscle.
  • Subcutaneous injection: An injection given under the skin.

Referencer

  1. https://clinicaltrials.gov/study/2024-511182-10-01
  2. https://kliniske-forsoeg.dk/forsog/undersoegelse-af-immunrespons-og-sikkerhed-ved-intramuskulaer-injektion-af-en-eksperimentel-skoldkoppevaccine-og-maeslinger-faaresyge-roede-hunde-vaccine-hos-raske-boern-i-alderen-12-15-maaneder/