Table of contents
- Trial overview
- Who participated
- What was studied
- Main outcomes measured
- Trial status and size
- What the results mean for patients
Trial overview
This clinical research studied RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) as part of a combined vaccine against measles, mumps, rubella, and varicella (chickenpox). The study was designed to compare the immune response and safety of the study vaccine with a marketed combined vaccine.[1]
The trial was an interventional study, which means researchers gave a vaccine and then measured the body’s response.[1] It was a Phase 2 trial, a stage that helps researchers learn more about how well a vaccine works while continuing safety checks.[1]
Who participated
The study enrolled healthy children 4 to 6 years of age.[1] The trial focused on children who were healthy volunteers and were being studied for prevention of measles, mumps, rubella, and varicella infections.[1]
- Healthy children: the trial did not focus on children with an active illness related to the diseases being prevented.[1]
- Age group 4 to 6 years: this age range helps researchers understand vaccine response in young children.[1]
What was studied
The study looked at a combined vaccine containing RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) together with measles, mumps, and varicella components.[1] The brief summary says the goal was to evaluate immune response in terms of antibody geometric mean concentrations for measles, mumps, rubella, and varicella viruses.[1]
The trial also compared different vaccine potencies within the MMRVNS vaccines and a pooled MMRV vaccine group.[1] In simple terms, researchers wanted to see whether the studied vaccine produced a similar or strong enough immune response compared with the reference vaccine.[1]
Main outcomes measured
The primary outcome was the geometric mean concentration (GMC) of antibodies at Day 43.[1] Antibodies are proteins made by the immune system after vaccination, and GMC is a way to describe the average level in the group.[1]
- Anti-measles antibody GMCs at Day 43.[1]
- Anti-mumps antibody GMCs at Day 43.[1]
- Anti-rubella antibody GMCs at Day 43.[1]
- Anti-glycoprotein E (gE) antibody GMCs at Day 43.[1]
Glycoprotein E (gE) is a protein used here as an immune marker for varicella-related response.[1] The study therefore measured how strongly the children’s immune systems responded to each part of the combined vaccine.[1]
Trial status and size
The trial status was Completed.[1] A total of 890 participants were enrolled.[1]
The study used a subcutaneous route of administration, which means the vaccine was given under the skin.[1] The trial compared the study vaccine with ProQuad, a marketed combined measles, mumps, rubella, and varicella vaccine.[1]
What the results mean for patients
This trial is mainly about whether a combined vaccine that includes RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) can produce a strong immune response in healthy young children.[1] The key focus was not disease treatment, but prevention through vaccination and comparison with an already marketed vaccine.[1]
For patients and families, the most important points are the target age group, the prevention goals, the Phase 2 design, and the antibody measurements taken after vaccination.[1] These details show that the study was designed to learn whether the vaccine response in children was adequate and how it compared with the reference product.[1]
