Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
NCT ID: NCT01621802
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4011 participants
INTERVENTIONAL
2012-06-21
2015-11-09
Brief Summary
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Detailed Description
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The Inv\_MMR vaccine will be administered as a second dose to children who already received a first dose Com\_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Inv _MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Priorix
One dose administered subcutaneously in the triceps region of the right arm.
Kinrix
One dose administered by deep intramuscular injection in the upper left deltoid.
ProQuad
One dose administered subcutaneously in the triceps region of the left arm.
Com_MMR_CO Group
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
M-M-R II
One dose administered subcutaneously in the triceps region of the right arm.
Kinrix
One dose administered by deep intramuscular injection in the upper left deltoid.
ProQuad
One dose administered subcutaneously in the triceps region of the left arm.
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
Priorix
One dose administered subcutaneously in the triceps region of the right arm.
Com_MMR_I Group
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
M-M-R II
One dose administered subcutaneously in the triceps region of the right arm.
Inv _MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Priorix
One dose administered subcutaneously in the triceps region of the right arm.
Com_MMR_S Group
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
M-M-R II
One dose administered subcutaneously in the triceps region of the right arm.
Interventions
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Priorix
One dose administered subcutaneously in the triceps region of the right arm.
M-M-R II
One dose administered subcutaneously in the triceps region of the right arm.
Kinrix
One dose administered by deep intramuscular injection in the upper left deltoid.
ProQuad
One dose administered subcutaneously in the triceps region of the left arm.
Eligibility Criteria
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Inclusion Criteria
* Male or female subjects 4 to 6 years of age at the time of vaccination.
* Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
* Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
* Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
* For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:
* subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
* subjects received a first dose of VV in the second year of life.
Exclusion Criteria
* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
* Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* History of measles, mumps, and/or rubella disease.
* Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin 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. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured 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 according to the subject's medical history.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:
* Previous vaccination with a second dose of varicella-containing vaccine.
* Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.
* History of varicella/zoster disease.
* Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.
* History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
* Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.
* Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.
* Following a previous administration of DTP vaccine: temperature ≥40.6°C (\>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.
* Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
4 Years
6 Years
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 (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Benton, Arkansas, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Baldwin Park, 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
Oakland, 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
Altamonte Springs, Florida, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Woodstock, Georgia, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Augusta, Kansas, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Columbia, Maryland, United States
GSK Investigational Site
Fall River, Massachusetts, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Asheboro, North Carolina, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Gresham, Oregon, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Cheraw, South Carolina, United States
GSK Investigational Site
Rapid City, South Dakota, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Tomball, Texas, United States
GSK Investigational Site
Provo, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
St. George, Utah, United States
GSK Investigational Site
Burke, Virginia, United States
GSK Investigational Site
Charlottesville, Virginia, United States
GSK Investigational Site
Huntington, West Virginia, United States
GSK Investigational Site
Monroe, Wisconsin, United States
GSK Investigational Site
Ansan, , South Korea
GSK Investigational Site
Daegu, , South Korea
GSK Investigational Site
Daejeon, , South Korea
GSK Investigational Site
Gyeonggi-do, , South Korea
GSK Investigational Site
GyeongSangNam-do, , South Korea
GSK Investigational Site
Iksan, , South Korea
GSK Investigational Site
Jeollabukdo, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Wonju-si Kangwon-do, , South Korea
GSK Investigational Site
New Taipei City, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taoyuan District, , Taiwan
Countries
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References
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MMR-158 Study Group. A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration. Hum Vaccin Immunother. 2019;15(4):786-799. doi: 10.1080/21645515.2018.1554971. Epub 2019 Feb 20.
Other Identifiers
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2011-004638-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
115158
Identifier Type: -
Identifier Source: org_study_id
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