What side effects are associated with this type of intervention?

The most common side effects of the MMRV vaccine, which combines measles, mumps, rubella, and varicella immunizations, include fever and rash. Specifically, fever was observed in approximately 27.7% of children, and measles-like rash occurred in about 5.9% of children within 5-12 days after the first dose. These side effects are generally mild and temporary. Serious side effects are rare but can include febrile seizures.

What prior FDA approvals exist?

The FDA has previously approved several vaccines for the prevention of Measles, Mumps, Rubella, and Chickenpox. The most notable combined vaccine is the MMR (Measles, Mumps, Rubella) vaccine, which has been widely used and is highly effective. Additionally, the MMRV vaccine, which includes Varicella (Chickenpox) along with Measles, Mumps, and Rubella, has also been approved and is used to provide comprehensive protection against these diseases in a single shot. These vaccines have been instrumental in reducing the incidence of these infections and are similar in purpose to the MMRVNS vaccine being studied, which aims to stimulate an immune response to all four viruses.

What other types of research exist?

Promising novel alternatives to the MMRVNS vaccine for measles, mumps, rubella, and chickenpox include mRNA-based vaccines and vector-based vaccines. mRNA vaccines, similar to those developed for COVID-19, are being explored for their ability to induce strong immune responses and rapid development timelines. Vector-based vaccines, which use a harmless virus to deliver antigens, are also under investigation for their efficacy and safety in preventing these diseases. These platforms offer the potential for improved immunogenicity and faster production compared to traditional vaccines.

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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

No Placebo-Only Group

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at day 1) for reporting.

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 more

Secondary 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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

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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.