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Virus Therapy

Combined Measles-Mumps-Rubella-Chickenpox Vaccine for Children's Immunization

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant who previously received a first dose of varicella-containing vaccine in the second year of life
Male or female between 4 and 6 years of age at the time of study intervention administration
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

Study Summary

This trial will assess the safety and effectiveness of different strengths of a vaccine against measles, mumps, rubella, and chickenpox in healthy children aged 4-6.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I received a chickenpox vaccine in my second year of life.
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I am between 4 and 6 years old.
Select...
I received a measles, mumps, and rubella vaccine dose in my second year of life.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-glycoprotein E (gE) antibody GMCs
Anti-measles antibody geometric mean concentrations (GMCs)
Anti-mumps antibody GMCs
+1 more
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,747 Previous Clinical Trials
8,066,592 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,178 Total Patients Enrolled

Media Library

Investigational M(L)M(L)R(L)V(L)NS vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05630846 — Phase 2
Measles, Mumps, Rubella and Chickenpox Research Study Groups: MMRV(H)NS Group, MM(H)RVNS Group, M(L)M(L)R(L)V(L)NS Group, MMRV_Lot 1 and Lot 2 Pooled Group
Measles, Mumps, Rubella and Chickenpox Clinical Trial 2023: Investigational M(L)M(L)R(L)V(L)NS vaccine Highlights & Side Effects. Trial Name: NCT05630846 — Phase 2
Investigational M(L)M(L)R(L)V(L)NS vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630846 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 25 or above eligible to participate in this research?

"This medical trial seeks patients who have not yet turned 6 years old, but are at least 4 years of age."

Answered by AI

What hazards might people be exposed to when associating with the MM(H)RVNS Group?

"Due to being in Phase 2, the Core Team at Power has determined that MM(H)RVNS Group's safety is a level 2. There is evidence of some degree of security yet no verifiable efficacy data."

Answered by AI

Are there still opportunities for participation in this experiment?

"This clinical trial, which was initially posted on December 14th 2022, is still actively recruiting participants. The most recent update of this study occurred on January 16th 2023 according to the information hosted by clinicaltrials.gov."

Answered by AI

How many physical sites are managing this clinical research?

"This clinical trial is accepting new participants at 10 sites, including Tampa, Louisville and Lincoln. To reduce the difficulties of travel associated with enrolment, it's best to select a clinic closest to your residence."

Answered by AI

Are there any qualifications required to be eligible for participation in this experiment?

"800 participants are needed for this research trial, who must have received the MMR and chickenpox vaccinations. Age of eligibility is between 4 to 6 years old."

Answered by AI

How many test subjects are participating in this clinical trial?

"Correct. The clinicaltrials.gov database verifies that the recruitment process for this study is ongoing - it was initially posted on December 14, 2022 and its most recent update occurred on January 16th 2023. A total of 800 participants are required to be enrolled across 10 different sites."

Answered by AI

What are the primary goals of this clinical experiment?

"As per the information provided by GlaxoSmithKline, the primary outcome for this investigation will be Anti-mumps antibody GMCs measured at Day 43. Additionally, secondary outcomes such as Seroresponse rate for measles (post-dose antibody concentration >= 67 mIU/mL), Seroresponse rate for rubella (post-dose antibody concentration >= 17 IU/mL) and Seroresponse rate for varicella (post-dose anti-gE antibody concentation >= 300 mIU/mL) will also be assessed."

Answered by AI
~356 spots leftby Mar 2025