Clinical trial NCT02184572: Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles; Mumps; Rubella
Measles-Mumps-Rubella Vaccine
Keywords: Rubella
Healthy children
Measles
Safety
Mumps
12 to 15 months
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 1742
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination
timeFrame: During Day 5 to Day 12 post-vaccination period
Secondary outcomes:
measure: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At Day 42 post vaccination
measure: Anti-measles Virus Antibody Concentrations
timeFrame: At Day 42 post vaccination
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At Day 42 post vaccination
measure: Anti-mumps Virus Antibody Concentrations
timeFrame: At Day 42 post vaccination
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At Day 42 post vaccination
measure: Anti-rubella Virus Antibody Concentrations
timeFrame: At Day 42 post vaccination
measure: Number of Subjects With Any Solicited Local Adverse Events (AEs)
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any Solicited General AEs
timeFrame: During the 15-day (Days 0-14) post-vaccination period
measure: Number of Subjects Reporting Any Fever
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Any Rash
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting MMR Specific Solicited General AEs
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Any Unsolicited AEs
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting AEs of Specific Interest
timeFrame: Day 0 through the end of the study (Day 180)
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: Day 0 through the end of the study (Day 180)
measure: Number of Subjects Reporting Measles-like Illness
timeFrame: During Day 5 to Day 12 post-vaccination period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
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country: United States
facility: GSK Investigational Site
state: Arkansas
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state: California
city: Baldwin Park
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state: California
city: Daly City
country: United States
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state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
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facility: GSK Investigational Site
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city: Paramount
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facility: GSK Investigational Site
state: California
city: Pleasanton
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state: California
city: Roseville
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state: California
city: Sacramento
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state: California
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city: Miami Lakes
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facility: GSK Investigational Site
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city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Augusta
country: United States
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state: Kansas
city: Newton
country: United States
facility: GSK Investigational Site
state: Kansas
city: Topeka
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Metairie
country: United States
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state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Frederick
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Niles
country: United States
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state: Michigan
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
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city: Omaha
country: United States
facility: GSK Investigational Site
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city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
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city: Syracuse
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state: New York
city: Asheboro
country: United States
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state: North Carolina
city: Boone
country: United States
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state: North Carolina
city: Clyde
country: United States
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state: North Carolina
city: Raleigh
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state: North Carolina
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country: United States
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state: North Dakota
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country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Cheraw
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Watertown
country: United States
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state: South Dakota
city: Kingsport
country: United States
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state: Tennessee
city: League City
country: United States
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state: Texas
city: Tomball
country: United States
facility: GSK Investigational Site
state: Texas
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Murray
country: United States
facility: GSK Investigational Site
state: Utah
city: Orem
country: United States
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state: Utah
city: Payson
country: United States
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state: Utah
city: Provo
country: United States
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state: Utah
city: Roy
country: United States
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state: Utah
city: Saint George
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Syracuse
country: United States
facility: GSK Investigational Site
state: Utah
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Ellensburg
country: United States
facility: GSK Investigational Site
state: Washington
city: Huntington
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Monroe
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Guayama
country: Puerto Rico
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: MMR-162 Study Group. Safety and immunogenicity of an upper-range release titer measles-mumps-rubella vaccine in children vaccinated at 12 to 15 months of age: a phase III, randomized study. Hum Vaccin Immunother. 2018;14(12):2921-2931. doi: 10.1080/21645515.2018.1502527. Epub 2018 Aug 29.