Table of contents
- Trial overview
- Who is studied
- What is being measured
- Phase and study design
- Main trials in the data
- Patient glossary
Trial overview
The clinical trials in this set study vaccines that include RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS as part of broader vaccination programs.[1][2] The main focus is not on the substance alone, but on how well vaccination works in children and adolescents, and whether the immune response is strong enough after vaccination or revaccination.[1][2]
Who is studied
One trial includes children and adolescents from 0 to 18 years old who have had childhood cancer.[1] Another trial includes healthy children 12 to 15 months of age.[2] This means the studies are looking at different pediatric groups, including children after cancer treatment and young children who are otherwise healthy.[1][2]
The cancer-related trial is about revaccination, which means giving vaccine doses again after treatment for childhood cancer.[1] The healthy-children trial compares different ways of giving vaccines, including intramuscular injection and subcutaneous injection, which means into the muscle or under the skin.[2]
What is being measured
The first trial measures the difference in IgG antibody levels before and after revaccination against chickenpox and measles.[1] In simple terms, the researchers want to see whether the body makes more protective antibodies after the vaccine is given again.[1]
The second trial measures seroresponse and antibody concentrations after vaccination.[2] Seroresponse means the immune system shows a clear response in the blood tests, while antibody concentration means how much of those protective antibodies are present.[2] The study looks at responses to varicella and to measles, mumps, and rubella antigens, which are the parts of the vaccine used to trigger immunity.[2]
Phase and study design
Both trials are Phase 3 studies.[1][2] Phase 3 studies are larger studies that help show whether a vaccine approach works well and how the immune response compares between groups.[2]
Both studies are interventional, which means researchers give the vaccine and then observe the results.[1][2] The first study is authorised and plans to enroll 160 participants, while the second is authorised and plans to enroll 944 participants.[1][2]
Main trials in the data
Trial 2024-511182-10-01 studies revaccination after childhood cancer treatment.[1] Its main goal is to compare protective antibody levels before and after vaccination against varicella and measles.[1] The study is authorised, is in Phase 3, and includes 160 children and adolescents aged 0 to 18 years with pediatric cancer.[1]
Trial NCT06855160 studies the immune response and safety of an investigational chickenpox vaccine and a marketed measles, mumps and rubella vaccine in healthy children 12 to 15 months old.[2] The study compares intramuscular and subcutaneous administration and looks for non-inferiority, which means it checks whether one method is not meaningfully worse than the other.[2] The main outcomes are seroresponse and antibody levels at Day 43 after vaccination.[2]
Patient glossary
Antibody: a protein made by the immune system to help protect against infection.[1][2]
IgG: a common type of antibody often used in blood tests to check protection after vaccination.[1]
Revaccination: giving a vaccine again after a person has already been vaccinated before.[1]
Seroresponse: a change in blood test results that shows the immune system reacted to the vaccine.[2]
Non-inferiority: a study goal that checks whether one option is not worse than another by more than a small amount.[2]
Intramuscular injection: an injection into a muscle.[2]
Subcutaneous injection: an injection under the skin.[2]
Enrollment: the number of people planned to join a study.[1][2]
