Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
2 other identifiers
interventional
1,259
2 countries
48
Brief Summary
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine. The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Typical duration for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedStudy Start
First participant enrolled
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2010
CompletedResults Posted
Study results publicly available
November 4, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2012
CompletedJanuary 3, 2020
December 1, 2019
1.1 years
March 12, 2009
July 14, 2011
December 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
At Day 42 after administration of a dose of Priorix vaccine.
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<24 ED50 prior to vaccination.
At Day 42 after administration of a dose of Priorix vaccine.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
At Day 42 after administration of a dose of Priorix vaccine.
Secondary Outcomes (40)
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
At Day 42 after administration of a dose of Varivax vaccine.
Anti-measles Virus Antibody Concentrations
At Day 42 after administration of a dose of Priorix vaccine.
Anti-mumps Virus Antibody Concentrations
At Day 42 after administration of a dose of Priorix vaccine.
Anti-rubella Virus Antibody Concentrations
At Day 42 after administration of a dose of Priorix vaccine.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
At Day 42 after vaccination
- +35 more secondary outcomes
Study Arms (4)
Priorix 1 Group
EXPERIMENTALSubjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Priorix 2 Group
EXPERIMENTALSubjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Priorix 3 Group
EXPERIMENTALSubjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
MMR-II Group
ACTIVE COMPARATORSubjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Interventions
Subcutaneous injection, one dose
Subcutaneous injection, one dose
Intramuscular injection, one dose
Intramuscular injection, one dose
Eligibility Criteria
You may qualify if:
- Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
- Written informed consent obtained from the parent/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- 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 (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
- History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Hypersensitivity to latex
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures, including febrile seizures.
- Acute disease at the time of enrolment.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (48)
GSK Investigational Site
Tuscaloosa, Alabama, 35401, United States
GSK Investigational Site
Conway, Arkansas, 72034, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Anaheim, California, 92804, United States
GSK Investigational Site
Downey, California, 90241, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Santa Ana, California, 92701-4607, United States
GSK Investigational Site
West Covina, California, 91790, United States
GSK Investigational Site
Altamonte Springs, Florida, 32701, United States
GSK Investigational Site
Dalton, Georgia, 30721, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Nampa, Idaho, 83686, United States
GSK Investigational Site
DeKalb, Illinois, 60115, United States
GSK Investigational Site
Arkansas City, Kansas, 67005, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Baltimore, Maryland, 21021, United States
GSK Investigational Site
Fall River, Massachusetts, 02724, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Great Falls, Montana, 59405, United States
GSK Investigational Site
Henderson, Nevada, 89015, United States
GSK Investigational Site
Utica, New York, 13502, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Dayton, Ohio, 45406, United States
GSK Investigational Site
Tulsa, Oklahoma, 74127, United States
GSK Investigational Site
Gresham, Oregon, 97030, United States
GSK Investigational Site
East Norriton, Pennsylvania, 19401, United States
GSK Investigational Site
Rydal, Pennsylvania, 19046, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Corpus Christi, Texas, 78411, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
Springville, Utah, 84663, United States
GSK Investigational Site
St. George, Utah, 84790, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Virginia Beach, Virginia, 23454, United States
GSK Investigational Site
Huntington, West Virginia, 25701, United States
GSK Investigational Site
Bayamón, 00959, Puerto Rico
GSK Investigational Site
San Germán, 00683, Puerto Rico
GSK Investigational Site
San Juan, 00936-5067, Puerto Rico
Related Publications (2)
Mufson MA, Diaz C, Leonardi M, Harrison CJ, Grogg S, Carbayo A, Carlo-Torres S, JeanFreau R, Quintero-Del-Rio A, Bautista G, Povey M, Da Costa C, Nicholson O, Innis BL. Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months. J Pediatric Infect Dis Soc. 2015 Dec;4(4):339-48. doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.
PMID: 26582873BACKGROUNDBerry AA, Abu-Elyazeed R, Diaz-Perez C, Mufson MA, Harrison CJ, Leonardi M, Twiggs JD, Peltier C, Grogg S, Carbayo A, Shapiro S, Povey M, Baccarini C, Innis BL, Henry O. Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin. Hum Vaccin Immunother. 2017 Jul 3;13(7):1516-1522. doi: 10.1080/21645515.2017.1309486. Epub 2017 May 8.
PMID: 28481690DERIVED
Related Links
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 2
- 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
March 12, 2009
First Posted
March 13, 2009
Study Start
June 3, 2009
Primary Completion
July 21, 2010
Study Completion
June 18, 2012
Last Updated
January 3, 2020
Results First Posted
November 4, 2011
Record last verified: 2019-12
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)