Completed

Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age

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What is being tested

Priorix

+ Varivax

+ Havrix

Biological
Who is being recruted

Infections+14

+ Measles

+ Stomatognathic Diseases

From 12 to 15 Months
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: August 2014
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 25, 2014

Actual date on which the first participant was enrolled.

This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV\_MMR vaccine) at a potency that will be used to define maximum release limits for the INV\_MMR in comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM\_MMR vaccine). In order to obtain more representative data on the comparator vaccine, the COM\_MMR used in this study will consist of two lots designated COM\_MMR\_L1 and COM\_MMR\_L2. Throughout the study COM\_MMR\_L1 and COM\_MMR\_L2 will be analyzed as pooled lots. This study is intended to support licensure of GSK's MMR vaccine in the US. All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to participants enrolled in selected non-US countries if local health departments do not routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and varicella vaccine is not part of the study procedures.

Official TitleSafety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age
NCT02184572
Principal SponsorGlaxoSmithKline
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1742 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 15 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsMeaslesStomatognathic DiseasesMouth DiseasesMumpsParotid DiseasesParotitisRNA Virus InfectionsRubellaSalivary Gland DiseasesTogaviridae InfectionsVirus DiseasesParamyxoviridae InfectionsMorbillivirus InfectionsRubivirus InfectionsMononegavirales InfectionsRubulavirus Infections

Criteria

Inclusion Criteria: * Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday until the day before age 16 months) at the time of vaccination. * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * Written informed consent obtained from the parent(s)/LAR(s) of the child. * Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history. * For US children only: a child who received all routine vaccinations as per ACIP recommendations prior to study entry: completion of hepatitis B and rotavirus series and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant series of Prevnar 13 should be completed at least 60 days prior to study vaccination. Exclusion Criteria: * Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period. * Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the study vaccination at Visit 1 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. * For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent. * Inhaled and topical steroids are allowed. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the day of study vaccination at Visit 1 and ending at Visit 2. Please Note: * Inactivated influenza (Flu) vaccine and monovalent Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s). * Any other age appropriate vaccine may be given starting at Visit 2 and anytime thereafter. * Administration of immunoglobulins and/or any blood products during the period starting 180 days before the study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2. * History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease. * Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination. * Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin. * 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 temperature ≥38.0°C/100.4°F by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever. * Active untreated tuberculosis based on medical history. * Any other condition which, in the opinion of the investigator, prevents the child from participating in the study. * For US children only: a child that previously received a fourth dose of PCV-13 vaccine.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects receive 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.

Group II

Active Comparator
Subjects receive 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 95 locations

Suspended

GSK Investigational Site

Birmingham, United StatesOpen GSK Investigational Site in Google Maps
Suspended

GSK Investigational Site

Tucson, United States
Suspended

GSK Investigational Site

Fayetteville, United States
Suspended

GSK Investigational Site

Jonesboro, United States
Completed95 Study Centers