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Combined Measles-Mumps-Rubella-Chickenpox Vaccine for Children's Immunization
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: MMRV(H)NS Group
- Group 2: MM(H)RVNS Group
- Group 3: M(L)M(L)R(L)V(L)NS Group
- Group 4: MMRV_Lot 1 and Lot 2 Pooled Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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