A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age
NCT ID: NCT05630846
Last Updated: 2025-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
801 participants
INTERVENTIONAL
2022-12-14
2024-10-14
Brief Summary
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Detailed Description
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This study will evaluate immunogenicity and safety using 3 MMRVNS formulations which vary for some or all the individual virus potencies. The 3 MMRVNS formulations (designated as MMRV(H)NS vaccine, MM(H)RVNS vaccine and M(L)M(L)R(L)V(L)NS vaccine) will be compared with the MMRV vaccine. To ensure representative data on the comparator, participants enrolled in the MMRV group will be randomized to two different lots (designated as MMRV\_Lot 1 and MMRV\_Lot 2). Throughout the study, the two lots will be analyzed as a pooled group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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MMRV(H)NS Group
Participants receive a single dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.
Investigational MMRV(H)NS vaccine
1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
MM(H)RVNS Group
Participants receive a single dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.
Investigational MM(H)RVNS vaccine
1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.
M(L)M(L)R(L)V(L)NS Group
Participants receive a single dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.
Investigational M(L)M(L)R(L)V(L)NS vaccine
1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
MMRV_Lot 1 and Lot 2 Pooled Group
Participants receive a single 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.
Marketed MMRV_Lot 1 and Lot 2 vaccine
1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously.
Interventions
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Investigational MMRV(H)NS vaccine
1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
Investigational MM(H)RVNS vaccine
1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.
Investigational M(L)M(L)R(L)V(L)NS vaccine
1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
Marketed MMRV_Lot 1 and Lot 2 vaccine
1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A male or female between, and including, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of study intervention administration, and in accordance with local regulations.
* Participant who previously received a first dose of varicella-containing vaccine in the second year of life.
* Participant who previously received a single dose of measles-, mumps-, rubella-containing vaccine in the second year of life.
* Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR\[s\]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations).
* Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries \[eDiaries\], return for follow-up visits).
Exclusion Criteria
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Hypersensitivity to latex.
* Major congenital defects, as assessed by the investigator.
* History of measles, mumps, rubella, or varicella disease.
* Recurrent history of or uncontrolled neurological disorders or seizures.
* Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as body temperature \>=38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit \[°F)\] by any age-appropriate route. All study interventions can be administered to participants with a minor illness such as diarrhea, mild upper respiratory infection without fever.
* Participant with history of coronavirus disease 2019 (COVID-19) who is still symptomatic.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior and Concomitant Therapy
* Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent \>= 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.
* Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
* Previous vaccination with a second dose of varicella-containing vaccine or measles-, mumps-, rubella-containing vaccine.
* Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration\* (Visit 3), with the exception of:
* inactivated influenza (flu) vaccine which may be given at any time during the study and administered at a different location than the study interventions and,
* routinely recommended licensed childhood DTPa-containing vaccines which can preferably be co-administered according to the local immunization practices of the participating country.
* Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter.
* In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local government recommendations and that GSK/IQVIA is notified accordingly.
Prior/Concurrent Clinical Study Experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
Other Exclusions
* Child in care.
* Any study personnel's immediate dependents, family, or household members.
* Participants with the following high-risk individuals in their household:
* Immunocompromised individuals
* Pregnant women without documented history of varicella.
* Newborn infants of mothers without documented history of varicella.
* Newborn infants born \<28 weeks of gestation.
4 Years
6 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Bellflower, California, United States
GSK Investigational Site
Huntington Park, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
San Jose, California, United States
GSK Investigational Site
Santa Clara, California, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Miami Lakes, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Ammon, Idaho, United States
GSK Investigational Site
Idaho Falls, Idaho, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Lafayette, Louisiana, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Simpsonville, South Carolina, United States
GSK Investigational Site
Tullahoma, Tennessee, United States
GSK Investigational Site
Dickinson, Texas, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
Richmond, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Provo, Utah, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
Barranquilla, , Colombia
GSK Investigational Site
Barranquilla, , Colombia
GSK Investigational Site
Bogotá, , Colombia
GSK Investigational Site
Riga, , Latvia
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taoyuan District, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-501564-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
217715
Identifier Type: -
Identifier Source: org_study_id
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