A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age

NCT07742644 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2177172025-523277-42-00
• Study Type: interventional
• Target: 1,860
• Locations: 6 countries
• Sites: 62

Brief Summary

The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine. The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s). The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.

Conditions

Measles; Mumps; Rubella; Varicella (Chickenpox); Measles-Mumps-Rubella+Chickenpox Vaccine

Keywords

Measles; Mumps; Rubella; Varicella (Chickenpox); Combined vaccine; Immunogenicity; Vaccine safety; Children aged 4 to 6 years

Outcome Measures

Primary Outcomes (3)

• Geometric mean concentrations (GMCs) of immunoglobulin G (IgG) antibodies against measles, mumps, rubella, and varicella zoster virus (VZV) glycoprotein E (gE) after MMRVNS vaccine administration

  This outcome measure evaluates immunological consistency.

  At Day 43

• Number of participants with seroresponse against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration

  This outcome measure evaluates immunological non-inferiority. Seroresponse is defined as post-vaccination IgG antibody concentrations equal to or above threshold values as follows: The seroresponse of a participant is: * zero (non-seroresponder) if the IgG concentration is below the seroresponse threshold of the assay, * One (seroresponder) if the IgG concentration is above or equal to the seroresponse threshold.

  At Day 43

• GMCs of IgG concentrations against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration

  This outcome measure evaluates immunological non-inferiority.

  At Day 43

Secondary Outcomes (8)

• GMCs of IgG antibodies against diphtheria, tetanus, and pertussis antigens (Bordetella pertussis toxin, filamentous hemagglutinin, and outer membrane protein pertactin) after MMRVNS or MMRV administration in a subset of participants

  At Day 43

• Geometric mean titers (GMTs) of neutralizing antibodies against poliovirus 1, 2, and 3 after MMRVNS or MMRV administration in a subset of participants

  At Day 43

• Booster response of IgG concentrations against pertussis antigens (Bordetella pertussis toxin, filamentous hemagglutinin, and outer membrane pertactin) after DTaP-IPV co-administration with MMRVNS or MMRV in a subset of participants

  At Day 43

• Number of participants with any solicited administration site events following MMRVNS or MMRV administration

  From Day 1 to Day 4 for injection site redness, pain/tenderness, and swelling; and from Day 1 to Day 43 for injection site varicella-like rash

• Number of participants with any solicited systemic events following MMRVNS or MMRV administration

  From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; Day 1 to Day 43 for varicella-like rash (non-injection site), measles/rubella-like rash, and other rash

Study Arms (4)

MMRVNS_Lot 1 group

EXPERIMENTAL

Participants will receive a single dose of the Lot 1 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.

Biological: MMRVNS vaccine; Biological: DTaP-IPV vaccine

MMRVNS_Lot 2 group

EXPERIMENTAL

Participants will receive a single dose of the Lot 2 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.

Biological: MMRVNS vaccine; Biological: DTaP-IPV vaccine

MMRVNS_Lot 3 group

EXPERIMENTAL

Participants will receive a single dose of the Lot 3 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.

Biological: MMRVNS vaccine; Biological: DTaP-IPV vaccine

MMRV group

ACTIVE COMPARATOR

Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.

Biological: MMRV vaccine; Biological: DTaP-IPV vaccine

Interventions

MMRVNS vaccine BIOLOGICAL

MMRVNS vaccine will be administered on Day 1.

MMRVNS_Lot 1 group; MMRVNS_Lot 2 group; MMRVNS_Lot 3 group

MMRV vaccine BIOLOGICAL

MMRV vaccine will be administered on Day 1.

Also known as: ProQuad

MMRV group

DTaP-IPV vaccine BIOLOGICAL

DTaP-IPV vaccine will be administered on Day 1.

Also known as: Kinrix

MMRV group; MMRVNS_Lot 1 group; MMRVNS_Lot 2 group; MMRVNS_Lot 3 group

Eligibility Criteria

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

You may qualify if:

• INC#1 Participant's 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 the eDiaries, return for follow-up visits).
• INC#2 Written or witnessed/thumb printed or digital informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study specific procedure.
• INC#3 Informed assent obtained from the participants in line with local rules and regulations.
• INC#4 Healthy participants as established by medical history and clinical examination at screening.
• INC#5 A male or female participant between and including 4 and 6 years of age (i.e., from fourth birthday until the day before the seventh birthday) at the time of the study interventions administration, and in accordance with local regulations.
• INC#6 Participant who previously received a first dose of varicella-containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
• INC#7 Participant who previously received a first dose of measles, mumps, rubella containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
• INC#8 Participant who previously received 3 or 4 doses of any combined DTP (DTaP/DTwP) vaccine (diphtheria and tetanus toxoids and pertussis antigens whether or not combined with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b antigens) according to the local recommendations.

You may not qualify if:

• EXC#1 History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or gelatin.
• EXC#2 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• EXC#3 Hypersensitivity to latex.
• EXC#4 Unstable chronic conditions as determined by medical history and physical examination.
• EXC#5 Major congenital defects, as assessed by the investigator.
• EXC#6 History of measles, mumps, rubella or varicella/zoster disease as evaluated by the investigator.
• EXC#7 History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
• EXC#8 Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures (including all subtypes, such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures).
• EXC#9 Active untreated tuberculosis.
• EXC#10 Condition that, in the judgment of the investigator, would make intramuscular injection unsafe.
• EXC#11 Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
• EXC#12 Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) 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.
• EXC#13 Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.
• EXC#14 Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.
• Up to 90 days prior to the study interventions administration.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (62)

Children's Clinic of Jonesboro, AR

Jonesboro, Arkansas, 72401, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Century Research Institute Inc

Huntington Park, California, 90255, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Center for Clinical Trials of Sacramento, Inc.

Sacramento, California, 95823, United States

Location

Center for Clinical Trials of San Gabriel

West Covina, California, 91790, United States

Location

BioMD Clinical Research

Coral Gables, Florida, 33134, United States

Location

D&H Pompano Research Center LLC

Margate, Florida, 33063, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Medical Research Partners

Ammon, Idaho, 83406, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2605, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

Norton Childrens Research Institute

Louisville, Kentucky, 40202, United States

Location

Benchmark Research

Covington, Louisiana, 70433, United States

Location

ACC Pediatric Research

Haughton, Louisiana, 71037, United States

Location

Velocity Clinical Research, Gulfport

Lafayette, Louisiana, 70508, United States

Location

Jefferson City Medical Group PC

Jefferson City, Missouri, 65109, United States

Location

Boeson Research MSO

Missoula, Montana, 59804, United States

Location

Midwest Children's Health Research Institute, LLC

Lincoln, Nebraska, 68504, United States

Location

Midwest Children's Health Research Institute, LLC

Lincoln, Nebraska, 68505, United States

Location

Complete Children's Health

Lincoln, Nebraska, 68516, United States

Location

Complete Children's Health

Lincoln, Nebraska, 68522-1231, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Senders Pediatrics

Cleveland, Ohio, 44121-4243, United States

Location

Neighbors Clinical Research

Charleston, South Carolina, 29407, United States

Location

Tribe Clinical Research LLC/Parkside Pediatrics

Greenville, South Carolina, 29607, United States

Location

Tribe Clinical Research LLC/Parkside Pediatrics

Simpsonville, South Carolina, 29681, United States

Location

Carolina Family Care

Summerville, South Carolina, 29486, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Tekton Research - Beaumont, TX

Beaumont, Texas, 77706, United States

Location

Pas Research

Edinburg, Texas, 78539, United States

Location

Pediatric Associates

Houston, Texas, 77087, United States

Location

Tanner Clinic Kaysville

Kaysville, Utah, 84037, United States

Location

Tanner Clinic Layton Parkway

Layton, Utah, 84041, United States

Location

Ogden Clinic Canyon View

Ogden, Utah, 84404, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23236, United States

Location

Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc

Marshfield, Wisconsin, 54449, United States

Location

Equipo Ciencia

Buenos Aires, Argentina

Location

Helios Salud

Ciudad Autonoma Buenos Aires, Argentina

Location

Clinica Privada del Sol SA

Córdoba, Argentina

Location

Clinica del Nino y la Familia de Mar del Plata

Mar del Plata, Argentina

Location

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Location

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Argentina

Location

Hospital del Nino Jesus

San Miguel de Tucumán, Argentina

Location

Finnish Vaccine Research, Espoo Clinic

Espoo, Finland

Location

Finnish Vaccine Research, Helsinki South Clinic

Helsinki, Finland

Location

Finnish Vaccine Research, Järvenpää Clinic

Jarvenpaa, Finland

Location

Finnish Vaccine Research, Kokkola Clinic

Kokkola, Finland

Location

Finnish Vaccine Research, Oulu Clinic

Oulu, Finland

Location

Finnish Vaccine Research, Seinäjoki Clinic

Seinäjoki, Finland

Location

Finnish Vaccine Research, Tampere Clinic

Tampere, Finland

Location

Finnish Vaccine Research, Turku Clinic

Turku, Finland

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

Location

Ospedale D'Avanzo

Foggia, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location

Centro Clin-PR

Corozal, Puerto Rico

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MacKay Memorial Hospital Taipei Branch

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan City, Taiwan

Location

MeSH Terms

Conditions

Measles; Mumps; Rubella; Chickenpox

Interventions

measles, mumps, rubella, varicella vaccine; DTPP 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

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an observer-blind study. In an observer-blind study, the participant, the site, and Sponsor personnel involved in the clinical evaluation of the participants are blinded while other study personnel may be aware of the treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): August 11, 2026
• Primary Completion (Estimated): June 27, 2028
• Study Completion (Estimated): November 21, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

US (38); FI (8); IT (3); PR (1); TW (5); AR (7)