Measles; Mumps; Rubella; ChickenpoxPhase 2NCT05630846
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
A Phase 2 study testing Investigational MMRV(H)NS vaccine, Investigational MM(H)RVNS vaccine and Investigational M(L)M(L)R(L)V(L)NS vaccine in people with Measles; Mumps; Rubella; Chickenpox and Measles, run by GlaxoSmithKline at 47 sites in 5 countries.
Trial summary
The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Measles; Mumps; Rubella; Chickenpox, Measles
- What is being tested?
- Investigational MMRV(H)NS vaccine, Investigational MM(H)RVNS vaccine and Investigational M(L)M(L)R(L)V(L)NS vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 47 sitesin 5 countries
- Study dates
- 14 Dec 2022to 14 Oct 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy participants as established by medical history and clinical examination before entering into the study.
- 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).
Who cannot join
- Medical Conditions
- 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.
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- 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.
Trial locations and contacts
47 sites in 5 countries.
47 sites in 5 countries
United States35 sites
GSK Investigational Site
Ammon, Idaho, 83406
GSK Investigational Site
Bellflower, California, 90706
GSK Investigational Site
Bingham Farms, Michigan, 48025
GSK Investigational Site
Birmingham, Alabama, 35235
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Dayton, Ohio, 45414
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Dickinson, Texas, 77539
GSK Investigational Site
Huntington Park, California, 90255
GSK Investigational Site
Idaho Falls, Idaho, 83404
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Lafayette, Louisiana, 70508
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lincoln, Nebraska, 68505
GSK Investigational Site
Lincoln, Nebraska, 68522
GSK Investigational Site
Louisville, Kentucky, 40291
GSK Investigational Site
McAllen, Texas, 78504
GSK Investigational Site
Miami Lakes, Florida, 33014
GSK Investigational Site
Oakland, California, 94611
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Richmond, Texas, 77469
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Roy, Utah, 84067
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
San Jose, California, 95119
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Tullahoma, Tennessee, 37388
GSK Investigational Site
West Covina, California, 91790
Taiwan5 sites
GSK Investigational Site
Taichung, 40447
GSK Investigational Site
Taichung, 407
GSK Investigational Site
Taipei, 10002
GSK Investigational Site
Taipei, 10449
GSK Investigational Site
Taoyuan, 333
Colombia3 sites
GSK Investigational Site
Barranquilla, 080020
GSK Investigational Site
Barranquilla, 760002
GSK Investigational Site
Bogotá, 38007
Puerto Rico3 sites
GSK Investigational Site
San Juan, 00907
GSK Investigational Site
San Juan, 00918
GSK Investigational Site
San Juan, 909
About this study
Official title: A Phase II, Single-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Measles, Mumps, Rubella, Varicella Vaccine Compared With ProQuad, Administered in Healthy Children 4-6 Years of Age
The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.
Read the detailed description
This study is designed to evaluate the immunogenicity and safety of the investigational measles, mumps, rubella, varicella vaccine (referred to as the MMRVNS vaccine) compared with the licensed measles, mumps, rubella, varicella vaccine, ProQuad (referred to as the MMRV vaccine), when given as a second dose to children 4 to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).
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
- Measles; Mumps; Rubella; Chickenpox, Measles
- Being tested
- Investigational MMRV(H)NS vaccine, Investigational MM(H)RVNS vaccine, Investigational M(L)M(L)R(L)V(L)NS vaccine, Marketed MMRV_Lot 1 and Lot 2 vaccine
- Keywords
- Measles, Mumps, Rubella, Varicella
- Medical subject headings
- Measles, Mumps, Rubella, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational MMRV(H)NS vaccineBiological
1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
Investigational MM(H)RVNS vaccineBiological
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 vaccineBiological
1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
Marketed MMRV_Lot 1 and Lot 2 vaccineBiological
Also called ProQuad
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.
| Study group | Role | What they receive |
|---|---|---|
| MMRV(H)NS Group | Experimental | 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. Receives: Biological: Investigational MMRV(H)NS vaccine |
| MM(H)RVNS Group | Experimental | 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. Receives: Biological: Investigational MM(H)RVNS vaccine |
| M(L)M(L)R(L)V(L)NS Group | Experimental | Participants receive a single dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1. Receives: Biological: Investigational M(L)M(L)R(L)V(L)NS vaccine |
| MMRV_Lot 1 and Lot 2 Pooled Group | Active comparator | 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. Receives: Biological: Marketed MMRV_Lot 1 and Lot 2 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMC of Anti-measles Antibodies at Day 43
Anti-measles antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in milli international units per milliliter (mIU/mL). Analysis was performed on per protocol set which included all eligible participants who received study intervention as per protocol, were not unblinded, had immunogenicity results pre- and post-dose for at least 1 antigen, complied with blood draw interval between study intervention and post- dose blood sample, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
GMC of Anti-mumps Antibodies at Day 43
Anti-mumps antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in arbitrary units per milliliter (AU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
GMC of Anti-rubella Antibodies at Day 43
Anti-rubella antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in international units per milliliter (IU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
GMC of Anti-glycoprotein E (gE) Antibodies at Day 43
Anti-gE antibodies were measured with enzyme linked immunosorbent assay and the results were expressed as GMC, in mIU/mL. Anti-varicella and anti-varicella zoster virus gE were used interchangeably. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
Secondary outcomes (9)
Percentage of Participants With Seroresponse for Measles Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 measles antibodies concentration was >=116 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 mumps antibodies concentration was >=296 AU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 rubella antibodies concentration was >=24 IU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 varicella antibodies concentration was >=300 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Measured: At Day 43
Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration
The solicited administration site events after vaccination included pain, erythema/redness, and swelling. Analysis was performed on exposed set which included all participants who received a study intervention. Only those participants with solicited AEs were included in this analysis.
Measured: Day 1 to Day 4
Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration
The solicited systemic events after vaccination included drowsiness and loss of appetite. Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
Measured: Day 1 to Day 4
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration
The solicited systemic events after vaccination included fever, measles/rubella-like rash, varicella- like rash and other rash (not measles/rubella-like rash or varicella-like rash). Fever was defined as temperature greater than or equal to 38.0 degrees Celsius (100.4 degrees Fahrenheit) by any route (the preferred location for measuring temperature is the axilla). Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
Measured: Day 1 to Day 43
Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or was included in the list of solicited events but with an onset outside the specified period of follow- up for solicited events. Unsolicited AEs must have been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious adverse events (SAEs) and non-serious AEs. Analysis was performed on exposed set.
Measured: Day 1 to Day 43
Number of Participants With SAEs After Vaccine Dose Administration
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or other significant medical events. Analysis was performed on exposed set.
Measured: Throughout the study period (Day 1 to Day 181)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start14 Dec 2022
- Primary completion7 Jun 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Measles; Mumps; Rubella; ChickenpoxStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630846
- Sponsor's protocol ID
- 217715
- Other IDs
- 2022-501564-18
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2022
- Last updated
- 22 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.