In short
Clinical trials investigating RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) study how well it works in vaccine combinations and how safe it is. The trial data here focus on healthy children, mainly ages 4 to 6 years, and measure the immune response after vaccination.
Key points
- Clinical trial data for RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) focus on a combined vaccine for measles, mumps, rubella, and chickenpox prevention. The study enrolled healthy children 4 to 6 years of age and was run as a Phase 2 interventional trial. It compared the study vaccine with a marketed combined vaccine. The main results measured antibody levels at Day 43 for measles, mumps, rubella, and varicella-related response. The trial was completed and included 890 participants.
Trial overview
This article covers one Phase 2 interventional study of RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) in a combined vaccine for measles, mumps, rubella, and chickenpox prevention. The study compared the trial vaccine with a marketed combined vaccine and focused on the body's immune response and safety.
Who participated
The trial enrolled healthy children 4 to 6 years of age. This means the study was done in children without the infections the vaccine is meant to help prevent.
What was tested
The study tested a combined measles, mumps, rubella, and varicella vaccine that included RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED). It also compared the trial vaccine with ProQuad, a marketed combined vaccine for measles, mumps, rubella, and varicella.
The brief summary says the study looked at vaccine formulations with different potencies and a pooled group for the MMRV vaccine. Potency means the strength of the vaccine formulation used in the study.
Outcomes measured
The main outcomes were antibody geometric mean concentrations at Day 43 for measles, mumps, rubella, and glycoprotein E (gE). Antibodies are proteins the immune system makes after vaccination, and geometric mean concentration is a way to summarize the average level in the group.
These measurements help show how strong the immune response was after vaccination. The trial also included anti-glycoprotein E antibody results, which were used as part of the response to the varicella component.
Trial status and size
The study was completed and enrolled 890 participants. A larger enrollment like this helps researchers compare immune responses across study groups more reliably.
Key points for patients
- The trial studied a vaccine combination, not a treatment for an active illness.
- The main goal was to measure immune response after vaccination, using antibody levels as the key test.
- The target group was healthy children 4 to 6 years old.
- The study was done in Phase 2 and has already been completed.
- The comparison vaccine was a marketed combined measles, mumps, rubella, and varicella vaccine.