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
NCT ID: NCT01702428
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5016 participants
INTERVENTIONAL
2012-11-09
2015-04-16
Brief Summary
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A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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INV_MMR_L1 Group
Subjects 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.
Priorix
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
Havrix
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
Prevnar 13
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
INV_MMR_L2 Group
Subjects 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.
Priorix
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
Havrix
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
Prevnar 13
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
INV_MMR_L3 Group
Subjects 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.
Priorix
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
Havrix
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
Prevnar 13
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
COM_MMR Group
Subjects 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.
M-M-R II
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
Havrix
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
Prevnar 13
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
Interventions
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Priorix
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
M-M-R II
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
Havrix
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
Prevnar 13
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Months
15 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Dothan, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Daly City, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Hayward, California, United States
GSK Investigational Site
Los Gatos, California, United States
GSK Investigational Site
Mission Hills, California, United States
GSK Investigational Site
Paramount, California, United States
GSK Investigational Site
Pleasanton, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Santa Clara, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Evergreen Park, Illinois, United States
GSK Investigational Site
Ames, Iowa, United States
GSK Investigational Site
Augusta, Kansas, United States
GSK Investigational Site
Overland Park, Kansas, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Bossier City, Louisiana, United States
GSK Investigational Site
Columbia, Maryland, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Fall River, Massachusetts, United States
GSK Investigational Site
Niles, Michigan, United States
GSK Investigational Site
Stevensville, Michigan, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Ithaca, New York, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Hermitage, Pennsylvania, United States
GSK Investigational Site
Sellersville, Pennsylvania, United States
GSK Investigational Site
Warwick, Rhode Island, United States
GSK Investigational Site
Barnwell, South Carolina, United States
GSK Investigational Site
Kingsport, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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League City, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Layton, Utah, United States
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Payson, Utah, United States
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Provo, Utah, United States
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Roy, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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St. George, Utah, United States
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Syracuse, Utah, United States
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West Jordan, Utah, United States
GSK Investigational Site
Charlottesville, Virginia, United States
GSK Investigational Site
Falls Church, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
GSK Investigational Site
Madison, Wisconsin, United States
GSK Investigational Site
Marshfield, Wisconsin, United States
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Espoo, , Finland
GSK Investigational Site
Helsinki, , Finland
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Helsinki, , Finland
GSK Investigational Site
Järvenpää, , Finland
GSK Investigational Site
Kokkola, , Finland
GSK Investigational Site
Oulu, , Finland
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Pori, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Durango, , Mexico
GSK Investigational Site
México, , Mexico
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
Castellon, , Spain
GSK Investigational Site
Castellon, , Spain
GSK Investigational Site
L'Eliana, Valencia, , Spain
GSK Investigational Site
Quart de Poblet, Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
Countries
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References
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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.
Other Identifiers
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2011-004891-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
115648
Identifier Type: -
Identifier Source: org_study_id
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