#1 Clinical Trials Search in Europe

RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)

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.

Table of contents

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.[1] The study compared the trial vaccine with a marketed combined vaccine and focused on the body’s immune response and safety.[1]

Who participated

The trial enrolled healthy children 4 to 6 years of age.[1] This means the study was done in children without the infections the vaccine is meant to help prevent.[1]

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).[1] It also compared the trial vaccine with ProQuad, a marketed combined vaccine for measles, mumps, rubella, and varicella.[1]

The brief summary says the study looked at vaccine formulations with different potencies and a pooled group for the MMRV vaccine.[1] Potency means the strength of the vaccine formulation used in the study.[1]

Outcomes measured

The main outcomes were antibody geometric mean concentrations at Day 43 for measles, mumps, rubella, and glycoprotein E (gE).[1] Antibodies are proteins the immune system makes after vaccination, and geometric mean concentration is a way to summarize the average level in the group.[1]

These measurements help show how strong the immune response was after vaccination.[1] The trial also included anti-glycoprotein E antibody results, which were used as part of the response to the varicella component.[1]

Trial status and size

The study was completed and enrolled 890 participants.[1] A larger enrollment like this helps researchers compare immune responses across study groups more reliably.[1]

Key points for patients

  • The trial studied a vaccine combination, not a treatment for an active illness.[1]

  • The main goal was to measure immune response after vaccination, using antibody levels as the key test.[1]

  • The target group was healthy children 4 to 6 years old.[1]

  • The study was done in Phase 2 and has already been completed.[1]

  • The comparison vaccine was a marketed combined measles, mumps, rubella, and varicella vaccine.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2022-501564-18-00Phase 2Healthy volunteers; prevention of measles, mumps, rubella, and varicella infectionsCompleted890

FAQ

  • What is being studied in these trials? The trials study a combined measles, mumps, rubella, and chickenpox vaccine that includes RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED). The main goal is to see how strong the immune response is after vaccination.
  • Who can take part in the trial shown here? The study enrolled healthy children 4 to 6 years of age. It focused on children without the illnesses being prevented, such as measles, mumps, rubella, and varicella.
  • What phase is this trial? This study is a Phase 2 trial. Phase 2 studies usually look more closely at immune response and safety in a larger group than early testing.
  • What results did the study measure? The main results were antibody geometric mean concentrations at Day 43. These were measured for measles, mumps, rubella, and glycoprotein E, which is a marker linked to varicella vaccine response.
  • What was the status of the trial? The trial was completed. It included 890 participants and compared the study vaccine with a marketed combined vaccine.

Ongoing Clinical Trials on RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)

  • Study on Immune Response and Safety of Measles, Mumps, Rubella, and Varicella Vaccine in Healthy Children Aged 4 to 6 Years

    Not yet recruiting

    2 1 1 1
    Investigated drugs:
    Latvia Spain

Glossary

  • Clinical trial: A research study in people that tests a vaccine or treatment and measures results such as safety or immune response.
  • Interventional study: A study where participants receive a vaccine or treatment so researchers can measure the effects.
  • Phase 2: A trial stage that looks more closely at how well a vaccine works and how safe it is in a larger group.
  • Healthy volunteers: People who do not have the condition being studied and join a trial to help test prevention or immune response.
  • Immune response: How the body reacts to a vaccine by making protection against an infection.
  • Antibody: A protein made by the immune system that helps fight infection and is often measured after vaccination.
  • Geometric mean concentration (GMC): A statistical way to show the average level of antibodies in a group.
  • Day 43: The time point used in the study to check antibody levels after vaccination.
  • Subcutaneous use: Given under the skin.
  • Varicella: Chickenpox.
  • Pooled group: A combined group of participants whose results are analyzed together.

References

  1. https://clinicaltrials.gov/study/2022-501564-18-00