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
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
2 other identifiers
interventional
5,016
5 countries
85
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2012
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2012
CompletedFirst Posted
Study publicly available on registry
October 8, 2012
CompletedStudy Start
First participant enrolled
November 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2015
CompletedResults Posted
Study results publicly available
June 28, 2018
CompletedNovember 25, 2019
November 1, 2019
2 years
October 4, 2012
August 5, 2016
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
At Day 42
Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
At Day 42
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
At Day 42
Anti-mumps Virus Antibody Concentration
Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
At Day 42
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
At Day 42
Anti-rubella Virus Antibody Concentration
Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
At Day 42
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV\_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV\_MMR lots is ≥90% for antibodies to measles virus.
At Day 42
Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
Antibody concentrations were expressed as GMCs in mIU/mL.
At Day 42
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination.
At Day 42
Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
Antibody concentrations were expressed as GMCs in EU/mL.
At Day 42
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV\_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV\_MMR lots is ≥90% for antibodies to rubella virus.
At Day 42
Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
Antibody concentrations were expressed as GMCs in IU/mL.
At Day 42
Secondary Outcomes (13)
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
At Day 42
Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
At Day 42
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
At Day 42
Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
At Day 42
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
At Day 42
- +8 more secondary outcomes
Study Arms (4)
INV_MMR_L1 Group
EXPERIMENTALSubjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV\_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
INV_MMR_L2 Group
EXPERIMENTALSubjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV\_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
INV_MMR_L3 Group
EXPERIMENTALSubjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV\_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
COM_MMR Group
ACTIVE COMPARATORSubjects receive 1 dose of COM\_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis is conducted for this group.
Interventions
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (90)
GSK Investigational Site
Dothan, Alabama, 36305, United States
GSK Investigational Site
Phoenix, Arizona, 85048, United States
GSK Investigational Site
Fayetteville, Arkansas, 72703, United States
GSK Investigational Site
Anaheim, California, 92804, United States
GSK Investigational Site
Daly City, California, 94015, United States
GSK Investigational Site
Fresno, California, 93726, United States
GSK Investigational Site
Hayward, California, 94545, United States
GSK Investigational Site
Los Gatos, California, 95032, United States
GSK Investigational Site
Mission Hills, California, 91345, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Pleasanton, California, 94588, United States
GSK Investigational Site
Sacramento, California, 95815, United States
GSK Investigational Site
Sacramento, California, 95823, United States
GSK Investigational Site
Santa Clara, California, 95051, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
GSK Investigational Site
Colorado Springs, Colorado, 80920, United States
GSK Investigational Site
Colorado Springs, Colorado, 80922, United States
GSK Investigational Site
Nampa, Idaho, 83686, United States
GSK Investigational Site
Evergreen Park, Illinois, 60805, United States
GSK Investigational Site
Ames, Iowa, 50010, United States
GSK Investigational Site
Augusta, Kansas, 67010, United States
GSK Investigational Site
Overland Park, Kansas, 66213, United States
GSK Investigational Site
Topeka, Kansas, 66604, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Columbia, Maryland, 21045, United States
GSK Investigational Site
Boston, Massachusetts, 02130, United States
GSK Investigational Site
Fall River, Massachusetts, 02721, United States
GSK Investigational Site
Niles, Michigan, 49120, United States
GSK Investigational Site
Stevensville, Michigan, 49127, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
The Bronx, New York, 10467, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Hermitage, Pennsylvania, 16148, United States
GSK Investigational Site
Sellersville, Pennsylvania, 18960, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Barnwell, South Carolina, 29812, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Fort Worth, Texas, 76107, United States
GSK Investigational Site
Houston, Texas, 77070, United States
GSK Investigational Site
League City, Texas, 77573, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Tomball, Texas, 77375, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Payson, Utah, 84651, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
Roy, Utah, 84067, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
St. George, Utah, 84790, United States
GSK Investigational Site
Syracuse, Utah, 84075, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Charlottesville, Virginia, 22902, United States
GSK Investigational Site
Falls Church, Virginia, 22042, United States
GSK Investigational Site
Richmond, Virginia, 23298, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Tallinn, 10117, Estonia
GSK Investigational Site
Tallinn, 10617, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tallinn, 13619, Estonia
GSK Investigational Site
Tartu, 50106, Estonia
GSK Investigational Site
Espoo, 02230, Finland
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00930, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Kokkola, 67100, Finland
GSK Investigational Site
Oulu, 90220, Finland
GSK Investigational Site
Pori, 28100, Finland
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Durango, 34000, Mexico
GSK Investigational Site
México, 04530, Mexico
GSK Investigational Site
San Juan, 00936-5067, Puerto Rico
GSK Investigational Site
Castellon, 12004, Spain
GSK Investigational Site
Castellon, 12530, Spain
GSK Investigational Site
L'Eliana, Valencia, 46183, Spain
GSK Investigational Site
Quart de Poblet, Valencia, 46930, Spain
GSK Investigational Site
Valencia, 46011, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Valencia, 46020, Spain
GSK Investigational Site
Valencia, 46022, Spain
GSK Investigational Site
Valencia, 46023, Spain
GSK Investigational Site
Valencia, 46200, Spain
Related Publications (1)
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.
PMID: 30849175BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2012
First Posted
October 8, 2012
Study Start
November 9, 2012
Primary Completion
November 25, 2014
Study Completion
April 16, 2015
Last Updated
November 25, 2019
Results First Posted
June 28, 2018
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- 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.
IPD is available via the Clinical Study Data Request site (click on the link provided below)