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

NCT05630846 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2177152022-501564-18
• Study Type: interventional
• Target: 801
• Locations: 5 countries
• Sites: 47

Brief 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.

Conditions

Measles; Mumps; Rubella; Chickenpox; Measles

Keywords

Measles; Mumps; Rubella; Varicella

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At Day 43

Secondary Outcomes (9)

• Percentage of Participants With Seroresponse for Measles Antibodies at Day 43

  At Day 43

• Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43

  At Day 43

• Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43

  At Day 43

• Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43

  At Day 43

• Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration

  Day 1 to Day 4

Study Arms (4)

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.

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.

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.

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.

Biological: Marketed MMRV_Lot 1 and Lot 2 vaccine

Interventions

Investigational MMRV(H)NS vaccine BIOLOGICAL

1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.

MMRV(H)NS Group

Investigational MM(H)RVNS vaccine BIOLOGICAL

1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.

MM(H)RVNS Group

Investigational M(L)M(L)R(L)V(L)NS vaccine BIOLOGICAL

1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.

M(L)M(L)R(L)V(L)NS Group

Marketed MMRV_Lot 1 and Lot 2 vaccine BIOLOGICAL

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.

Also known as: ProQuad

MMRV_Lot 1 and Lot 2 Pooled Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (47)

GSK Investigational Site

Birmingham, Alabama, 35235, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Bellflower, California, 90706, United States

Location

GSK Investigational Site

Huntington Park, California, 90255, United States

Location

GSK Investigational Site

Oakland, California, 94611, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

Sacramento, California, 95815, United States

Location

GSK Investigational Site

Sacramento, California, 95823, United States

Location

GSK Investigational Site

San Jose, California, 95119, United States

Location

GSK Investigational Site

Santa Clara, California, 95051, United States

Location

GSK Investigational Site

West Covina, California, 91790, United States

Location

GSK Investigational Site

Miami Lakes, Florida, 33014, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

Ammon, Idaho, 83406, United States

Location

GSK Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40291, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70508, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02118, United States

Location

GSK Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

GSK Investigational Site

Detroit, Michigan, 48201, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68505, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68522, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68114, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

GSK Investigational Site

Dayton, Ohio, 45414, United States

Location

GSK Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

GSK Investigational Site

Tullahoma, Tennessee, 37388, United States

Location

GSK Investigational Site

Dickinson, Texas, 77539, United States

Location

GSK Investigational Site

McAllen, Texas, 78504, United States

Location

GSK Investigational Site

Richmond, Texas, 77469, United States

Location

GSK Investigational Site

Layton, Utah, 84041, United States

Location

GSK Investigational Site

Provo, Utah, 84604, United States

Location

GSK Investigational Site

Roy, Utah, 84067, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

Barranquilla, 080020, Colombia

Location

GSK Investigational Site

Barranquilla, 760002, Colombia

Location

GSK Investigational Site

Bogotá, 38007, Colombia

Location

GSK Investigational Site

Riga, LV1002, Latvia

Location

GSK Investigational Site

San Juan, 00907, Puerto Rico

Location

GSK Investigational Site

San Juan, 00918, Puerto Rico

Location

GSK Investigational Site

San Juan, 909, Puerto Rico

Location

GSK Investigational Site

Taichung, 40447, Taiwan

Location

GSK Investigational Site

Taichung, 407, Taiwan

Location

GSK Investigational Site

Taipei, 10002, Taiwan

Location

GSK Investigational Site

Taipei, 10449, Taiwan

Location

GSK Investigational Site

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Measles; Mumps; Rubella; Chickenpox

Interventions

measles, mumps, rubella, varicella vaccine

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline Biologicals SA

GSKClinicalSupportHD@gsk.com

8664357343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Single-blind study. Recipients and care providers will be unaware of vaccine administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: November 30, 2022
• Study Start: December 14, 2022
• Primary Completion: June 7, 2024
• Study Completion: October 14, 2024
• Last Updated: June 22, 2025
• Results First Posted: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

PR (3); LA (1); CO (3); TW (5); US (35)