Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
NCT ID: NCT01681992
Last Updated: 2021-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4538 participants
INTERVENTIONAL
2012-10-10
2015-08-18
Brief Summary
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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_Min Group
Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a minimum potency lot (Inv\_MMR\_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Priorix
Subjects receive one dose of either minimum (Inv\_MMR\_Min) or medium (Inv\_MMR\_Med) potency lot at Day 0 and a dose of separate potency lot (Inv\_MMR\_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
Havrix
Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.
Prevnar 13
US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
Inv_MMR_Med Group
Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Priorix
Subjects receive one dose of either minimum (Inv\_MMR\_Min) or medium (Inv\_MMR\_Med) potency lot at Day 0 and a dose of separate potency lot (Inv\_MMR\_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
Havrix
Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.
Prevnar 13
US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
Com_MMR Group
Subjects receive one dose of M-M-R II (Com\_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
M-M-R II
Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
Havrix
Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.
Prevnar 13
US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
Interventions
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Priorix
Subjects receive one dose of either minimum (Inv\_MMR\_Min) or medium (Inv\_MMR\_Med) potency lot at Day 0 and a dose of separate potency lot (Inv\_MMR\_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.
M-M-R II
Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.
Varivax
Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
Havrix
Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.
Prevnar 13
US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
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 with 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 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.
* 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 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:
* Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
* Any age appropriate vaccine may be given starting at Visit 2 (or starting at Visit 3 for the US post-dose 2 sub-cohort), 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, or at Visit 3 for the US post-dose 2 sub-cohort.
* History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
* Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the 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. 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 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 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
Birmingham, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Altamonte Springs, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami Lakes, Florida, United States
GSK Investigational Site
Naples, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Muncie, Indiana, United States
GSK Investigational Site
New Albany, Indiana, United States
GSK Investigational Site
West Des Moines, Iowa, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Annapolis, Maryland, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Frederick, Maryland, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Clyde, North Carolina, 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
Toledo, Ohio, United States
GSK Investigational Site
Youngstown, Ohio, United States
GSK Investigational Site
Gresham, Oregon, United States
GSK Investigational Site
Johnstown, Pennsylvania, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Springville, Utah, United States
GSK Investigational Site
St. George, Utah, United States
GSK Investigational Site
Midlothian, Virginia, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Ellensburg, Washington, United States
GSK Investigational Site
Benešov, , Czechia
GSK Investigational Site
Chlumec nad Cidlinou, , Czechia
GSK Investigational Site
Děčín, , Czechia
GSK Investigational Site
Jindřichův Hradec, , Czechia
GSK Investigational Site
Kladno, , Czechia
GSK Investigational Site
Liberec, , Czechia
GSK Investigational Site
Lipník nad Bečvou, , Czechia
GSK Investigational Site
Náchod, , Czechia
GSK Investigational Site
Odolena Voda, , Czechia
GSK Investigational Site
Ostrava - Poruba, , Czechia
GSK Investigational Site
Pardubice, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Järvenpää, , Finland
GSK Investigational Site
Oulu, , Finland
GSK Investigational Site
Tampere, , Finland
GSK Investigational Site
Turku, , Finland
GSK Investigational Site
Kuala Terengganu, , Malaysia
GSK Investigational Site
Kuching, , Malaysia
GSK Investigational Site
Sibu, , Malaysia
GSK Investigational Site
Guayama, , Puerto Rico
GSK Investigational Site
Ponce, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
Antequera/Málaga, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Centelles (Barcelona), , Spain
GSK Investigational Site
L'Eliana, Valencia, , Spain
GSK Investigational Site
Manlleu, , Spain
GSK Investigational Site
Quart de Poblet, Valencia, , Spain
GSK Investigational Site
Santiago de Compostela, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Vic, , Spain
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Chiang Mai, , Thailand
GSK Investigational Site
Pathum Thani, , Thailand
Countries
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References
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MMR-161 Study Group. Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial. Vaccine. 2018 Sep 11;36(38):5781-5788. doi: 10.1016/j.vaccine.2018.07.076. Epub 2018 Aug 10.
Other Identifiers
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2011-004905-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
115649
Identifier Type: -
Identifier Source: org_study_id
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