In short
Clinical trials investigating MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED) are looking at vaccine immune response and safety in healthy children. The studies compare combined vaccines and different ways of giving them, with a focus on protection against measles and related infections.
Key points
- Clinical trials of MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED) are studying vaccine immune response and safety, mostly in healthy children. One Phase 3 study includes children 12 to 15 months old, and one Phase 2 study includes children 4 to 6 years old. The trials compare combined vaccines and different routes of giving them, such as intramuscular and subcutaneous use. Main outcomes include seroresponse and antibody levels measured at Day 43. The conditions studied include measles, mumps, rubella, and varicella, also called chickenpox.
Trial overview
These studies investigate vaccines that include MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED) as part of combined vaccination programs. The trials focus on immune response and safety in children, not on treating an active illness.
Two trials are listed here. One is a Phase 3 study in healthy children 12 to 15 months of age, and the other is a Phase 2 study in healthy children 4 to 6 years of age.
Studied populations
The first trial includes healthy children 12 to 15 months old and studies varicella prevention together with measles, mumps, and rubella vaccination. The second trial includes healthy children 4 to 6 years old and evaluates a combined measles, mumps, rubella, and varicella vaccine.
- Healthy children 12 to 15 months of age: this group is used to see how well the vaccine response develops at the usual early childhood vaccination age.
- Healthy children 4 to 6 years of age: this group helps researchers compare immune response in older children who receive combined vaccine schedules.
Trial designs and phases
Both studies are interventional, which means researchers give a vaccine and then measure the results. The Phase 3 trial uses a larger group of children, while the Phase 2 trial is focused on immune response testing in a smaller development stage.
The Phase 3 study compares intramuscular administration of the investigational vaccine with subcutaneous administration of a marketed comparator vaccine. The Phase 2 study compares different potencies of the combined vaccine with a marketed combined vaccine.
- Interventional: the trial team gives the vaccine to study participants and then observes the immune response.
- Non-inferiority: a test to show that one vaccine is not worse than another by more than a small, set amount.
- Comparator vaccine: the vaccine used as the reference point for comparison in the study.
Main outcomes measured
The main outcomes in these trials are immune response measures taken at Day 43 after vaccination. Researchers measure seroresponse and antibody concentrations for measles, mumps, rubella, and varicella-related antigens.
- Seroresponse to VZV gE: checks whether the body makes a clear immune response to varicella zoster virus glycoprotein E at Day 43.
- Anti-VZV gE IgG concentration: measures the level of IgG antibodies, a type of protective antibody, against varicella zoster virus glycoprotein E.
- Seroresponse to MMR antigens: checks immune response to measles, mumps, and rubella parts of the vaccine.
- Anti-measles, anti-mumps, and anti-rubella IgG concentration: measures the amount of these antibodies in the blood after vaccination.
- Geometric mean concentration (GMC): the average antibody level used to compare groups in the study.
In the Phase 2 trial, the primary outcomes are anti-measles, anti-mumps, anti-rubella, and anti-glycoprotein E antibody geometric mean concentrations at Day 43. In the Phase 3 trial, the main focus is whether the immune response after intramuscular use is not inferior to the subcutaneous route.
What the studies compare
The Phase 3 trial compares an investigational chickenpox vaccine given by intramuscular injection with a marketed varicella vaccine given under the skin, and it also compares intramuscular and subcutaneous use of the combined measles, mumps, and rubella vaccine. This helps researchers see whether the new way of giving the vaccine gives a similar immune response.
The Phase 2 trial compares combined vaccines with different potencies against a marketed combined vaccine. The goal is to evaluate the immune response to measles, mumps, rubella, and varicella components in a controlled research setting.
- Intramuscular injection: vaccine given into a muscle.
- Subcutaneous use: vaccine given under the skin.
- Potency: the strength of a vaccine preparation used in the study.
What the results mean for patients
For families, these trials are mainly about learning whether combined childhood vaccines produce a strong immune response and whether different ways of giving them work well. The trials do not report treatment of disease; they are preventive vaccine studies in healthy children.
The information collected may help researchers decide whether a vaccine schedule is effective enough to move forward in development or use in children. The key question is whether the vaccine creates the expected antibody response after vaccination.