Clinical trial NCT01702428: Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
Official title: Consistency Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Healthy Children 12 to 15 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rubella
Measles
Mumps
Keywords: Safety
Consistency study
Measles, mumps and rubella diseases
Healthy children
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 5016
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 consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

Detailed description: This study will evaluate the consistency of the immune response to three different lots of GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine, throughout this document) and compare its immunogenicity to the US standard of care comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as COM_MMR throughout this document) in children during their second year of life. The INV_MMR vaccine will be given as one of three consistency lots manufactured to target potencies designated as INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.

Eligibility criteria: Inclusion Criteria:

* Male or female child between 12 and 15 months of age at the time of vaccination.
* The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, 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:

• Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), with the last dose at least 60 days prior to study entry.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product 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.
* Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose 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 study vaccination at Visit 1 and ending at Visit 2. Please Note:

  * Inactivated influenza (Flu) vaccine and 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 prior to 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.
* 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.
* Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Acute disease at the time of enrollment. 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:

* Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only).
* Child that previously received a fourth dose of any pneumococcal conjugate vaccine.

Primary outcomes:
measure: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At Day 42
measure: Anti-measles Virus Antibody Concentrations
timeFrame: At Day 42
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At Day 42
measure: Anti-mumps Virus Antibody Concentration
timeFrame: At Day 42
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At Day 42
measure: Anti-rubella Virus Antibody Concentration
timeFrame: At Day 42
measure: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
timeFrame: At Day 42
measure: Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
timeFrame: At Day 42
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
timeFrame: At Day 42
measure: Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
timeFrame: At Day 42
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
timeFrame: At Day 42
measure: Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
timeFrame: At Day 42
Secondary outcomes:
measure: Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
timeFrame: At Day 42
measure: Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
timeFrame: At Day 42
measure: Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
timeFrame: At Day 42
measure: Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
timeFrame: At Day 42
measure: Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
timeFrame: At Day 42
measure: Number of Subjects With Any Solicited Local Adverse Events (AEs)
timeFrame: During the 4-days (Days 0-3) post-vaccination period
measure: Number of Subjects With Any Solicited General AEs
timeFrame: During the 15-days (Days 0-14) post-vaccination period
measure: Number of Subjects Reporting Any Fever
timeFrame: During the 43-days (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Any Rash
timeFrame: During the 43-days (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Any MMR Specific Solicited AEs
timeFrame: During the 43-days (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Any Unsolicited AEs
timeFrame: During the 43-days (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting AEs of Specific Interest
timeFrame: From Day 0 through the end of study (Day 180)
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: From Day 0 through the end of study (Day 180)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Daly City
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Hayward
country: United States
facility: GSK Investigational Site
state: California
city: Los Gatos
country: United States
facility: GSK Investigational Site
state: California
city: Mission Hills
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: Pleasanton
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Santa Clara
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Evergreen Park
country: United States
facility: GSK Investigational Site
state: Illinois
city: Ames
country: United States
facility: GSK Investigational Site
state: Iowa
city: Augusta
country: United States
facility: GSK Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: GSK Investigational Site
state: Kansas
city: Topeka
country: United States
facility: GSK Investigational Site
state: Kansas
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Niles
country: United States
facility: GSK Investigational Site
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: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Ithaca
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hermitage
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Barnwell
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: League City
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
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: Payson
country: United States
facility: GSK Investigational Site
state: Utah
city: Provo
country: United States
facility: GSK Investigational Site
state: Utah
city: Roy
country: United States
facility: GSK Investigational Site
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: Salt Lake City
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: Falls Church
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
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: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: Castellón
country: Spain
facility: GSK Investigational Site
city: Castellón
country: Spain
facility: GSK Investigational Site
city: L'Eliana, Valencia
country: Spain
facility: GSK Investigational Site
city: Quart De Poblet, Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201. doi: 10.1093/jpids/piz010.