This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02058563
First received: February 6, 2014
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.

Condition Intervention Phase
Rubella Mumps Measles Biological: Priorix® Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-measles Virus Antibody Concentrations. [ Time Frame: At Day 42 ]
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.

  • Anti-mumps Virus Antibody Concentrations [ Time Frame: At Day 42 ]
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL

  • Anti-rubella Virus Antibody Concentrations. [ Time Frame: At Day 42 ]
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL


Secondary Outcome Measures:
  • Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate) [ Time Frame: At Day 42 ]

    Seroresponse was defined as:

    Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.


  • Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate). [ Time Frame: At Day 42 ]

    Seroresponse was defined as:

    Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.


  • Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate). [ Time Frame: At Day 42 ]

    Seroresponse was defined as:

    Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.


  • Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations. [ Time Frame: At Day 42 ]
    For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.

  • Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter >50mm. Grade 3 swelling = swelling with surface diameter >50mm.

  • Number of Subjects Reporting Fever [ Time Frame: During the 43 days (Days 0-42) post-vaccination period. ]
    Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever >39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.

  • Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. [ Time Frame: During the 43 days (Days 0-42) post-vaccination period. ]
    Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.

  • Number of Subjects Reporting Unsolicited AEs [ Time Frame: During the 43 days (Days 0-42) post-vaccination period. ]
    Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  • Number of Subjects Reporting Solicited Rash Symptom [ Time Frame: During the 43 days (Days 0-42) post-vaccination period. ]
    Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.

  • Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis) [ Time Frame: During the 43 days (Days 0-42) post-vaccination period. ]
    Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.

  • Number of Subjects Reporting NOCDs [ Time Frame: Day 0 through the end of the study (Day 180) ]
    Occurrence of new onset chronic diseases (NOCDs)

  • Number of Subjects Reporting Adverse Events Prompting ER Visits [ Time Frame: Day 0 through the end of the study (Day 180) ]
    Occurrence of AEs prompting emergency room (ER) visits.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Day 0 through the end of the study (Day 180) ]
    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.


Enrollment: 996
Study Start Date: July 1, 2014
Study Completion Date: September 17, 2015
Primary Completion Date: May 24, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INV_MMR Group
Subjects will receive 1 dose of GSK Biologicals' trivalent Measles, Mumps, and Rubella Virus Vaccine (Priorix®).
Biological: Priorix®
1 dose administered as a subcutaneous (SC) injection.
Active Comparator: COM_MMR Group
Subjects will receive 1 dose of Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine.
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
1 dose administered subcutaneously.

Detailed Description:
This study will evaluate the immunogenicity of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) in contrast to the US standard of care (M-M-R®II, Merck and Company, referred to as COM_MMR) when both are used as a second dose in subjects 7 years of age and older. In this study, the INV_MMR vaccine may be administered as a second dose to persons with either a history or formal documentation of at least one dose immunization with any MMR vaccine. This study is intended to support licensure of GSK's MMR vaccine in the US.
  Eligibility

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Male or female subjects 7 years of age or older and born after December 31, 1956*. *The only exception to this is health care workers born before 1957 without other evidence of immunity to mumps for which one dose of a live mumps virus vaccine is recommended; therefore this population is eligible for enrollment in this study.
  • For all children 7-17 years of age:

    • Written documentation of prior receipt of 1 dose of MMR vaccine administered on or after the first birthday.
  • For all adults 18 years of age and older:

    • Prior receipt (written or verbal history) of at least one dose of MMR vaccine.
    • Birth in the US.
  • Written informed consent obtained from the subject or from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects who are still legally minors in line with local rules and regulations).
  • Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, or ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject

    • Has agreed to be abstinent or practiced adequate contraception during the entire period starting 30 days prior to vaccination(s) until 3 months after receipt of the study vaccination and
    • has a negative pregnancy test on the day of vaccination.

Exclusion Criteria:

  • Child in care.
  • For all children 7-17 years of age:

    • Previous receipt of more than 1 dose of a measles-containing vaccine.
  • Use of any investigational or non-registered product other than the study vaccine(s), during the period starting 30 days preceding the day of study vaccination, (i.e. 30 days prior to Day 0) or planned use during the entire study period.
  • Receipt of any measles, mumps or rubella-containing vaccine during the period starting 42 days before the day of study vaccination (i.e. 42 days prior to Day 0).
  • Chronic administration (defined as 14 or more consecutive days) of immunosuppressants or other immune-modifying drugs during the period starting 180 days before study vaccination or any planned administration of 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 prior to study vaccination through the immunogenicity evaluation at Visit 2 or Visit 3 (for one-dose or two-dose cohort, respectively).
  • Planned administration/ administration of any live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination and ending at Visit 2. Live intranasal influenza vaccine or any inactivated vaccine required in the age group may be given at any time, including the day of study vaccination.
  • 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, or rubella disease.
  • Known exposure to measles, mumps, or rubella, during the period starting 30 days before study start (i.e. 30 days prior to Day 0).
  • %
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058563

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35211
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Mesa, Arizona, United States
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33144
GSK Investigational Site
Miami, Florida, United States, 33176
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60654
United States, Minnesota
GSK Investigational Site
Edina, Minnesota, United States, 55435
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45249
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Estonia
GSK Investigational Site
Tartu, Estonia, 50106
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 851 01
GSK Investigational Site
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site
Dunajska Streda, Slovakia, 929 01
GSK Investigational Site
Martin, Slovakia, 036 01
GSK Investigational Site
Ruzomberok, Slovakia, 034 01
GSK Investigational Site
Zlate Moravce, Slovakia, 953 01
Sponsors and Collaborators
GlaxoSmithKline
Parexel
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02058563     History of Changes
Other Study ID Numbers: 115231
2011-003672-36 ( EudraCT Number )
Study First Received: February 6, 2014
Results First Received: December 30, 2016
Last Updated: May 8, 2017

Keywords provided by GlaxoSmithKline:
Measles, mumps and rubella diseases
Safety
Immunogenicity

Additional relevant MeSH terms:
Measles
Rubella
Mumps
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017