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Virus Therapy
Combined Measles-Mumps-Rubella-Chickenpox Vaccine for Children's Immunization
Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 43-day (day of administration and 42 following days) period after the administration of study interventions (administered at day 1)
Awards & highlights
Summary
This trial tests the immune response and safety of different strengths of a combined vaccine for measles, mumps, rubella, and chickenpox in young children. The combination vaccine has been shown to be an effective and safe approach to immunization in healthy children.
Who is the study for?
Healthy children aged 4-6 who've had their first measles, mumps, rubella, and chickenpox vaccines. They must not have immune system issues or severe reactions to vaccine components like neomycin or gelatin. Parents must consent and be able to follow the study's requirements.
What is being tested?
The trial is testing different strengths of a combined measles, mumps, rubella, and chickenpox (MMRVNS) vaccine against two standard doses of a marketed MMRV vaccine in healthy kids to see how well they respond and if it's safe.
What are the potential side effects?
Possible side effects include pain at the injection site, fever, rash, mild illness similar to colds without fever. Severe allergic reactions are rare but can occur due to ingredients like neomycin or gelatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at day 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at day 1)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anti-glycoprotein E (gE) antibody GMCs
Anti-measles antibody geometric mean concentrations (GMCs)
Anti-mumps antibody GMCs
+1 moreSecondary study objectives
Percentage of participants reporting each solicited administration site event
Percentage of participants reporting each solicited systemic event in terms of drowsiness and loss of appetite
Percentage of participants reporting each solicited systemic event in terms of fever, measles/rubella-like rash, varicella-like rash and other rash (not measles/rubella-like rash or varicella-like rash)
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: MMRV(H)NS GroupExperimental Treatment1 Intervention
Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.
Group II: MM(H)RVNS GroupExperimental Treatment1 Intervention
Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.
Group III: M(L)M(L)R(L)V(L)NS GroupExperimental Treatment1 Intervention
Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.
Group IV: MMRV_Lot 1 and Lot 2 Pooled GroupActive Control1 Intervention
Healthy children aged 4 to 6 years of age receive 1 dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The MMRVNS vaccine, similar to the combined MMRV vaccine, works by stimulating the immune system to produce a response against Measles, Mumps, Rubella, and Chickenpox. It contains live attenuated viruses that are weakened and cannot cause disease in healthy individuals but are strong enough to trigger the immune system to recognize and combat the actual viruses if exposed in the future.
This immune response includes the production of antibodies and memory cells, providing long-term protection. This mechanism is essential for preventing these diseases and their severe complications, especially in children, and simplifies the vaccination process by offering broader protection with fewer injections.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,794 Previous Clinical Trials
8,176,860 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,602 Previous Clinical Trials
6,144,083 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had COVID-19 and still have symptoms.I have received the second dose of the chickenpox or MMR vaccine.I received a chickenpox vaccine in my second year of life.I am taking long-term immune system altering medications.I have a condition that weakens my immune system.I have uncontrolled seizures or neurological disorders.I have not received immunoglobulins, blood products, or plasma derivatives.I am not on long-term immune system drugs.I am between 4 and 6 years old.I received a measles, mumps, and rubella vaccine dose in my second year of life.
Research Study Groups:
This trial has the following groups:- Group 1: MMRV(H)NS Group
- Group 2: MM(H)RVNS Group
- Group 3: MMRV_Lot 1 and Lot 2 Pooled Group
- Group 4: M(L)M(L)R(L)V(L)NS Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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