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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • 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


Original Primary Outcome: Seroresponse of INV_MMR vaccine as compared to COM_MMR vaccine [ Time Frame: 42 days after the last study vaccination (either Day 42 or Day 84) ]

Current Secondary Outcome:

  • 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;

    Original Secondary Outcome:

    • Immunogenicity of the INV_MMR vaccine as compared to the COM_MMR vaccine in terms of antibody concentrations [ Time Frame: 42 days after the last study vaccination (either Day 42 or Day 84) ]
    • Occurrence of solicited local symptoms [ Time Frame: From Day 0 to Day 3 after each vaccination ]
    • Occurrence of solicited general symptoms [ Time Frame: From Day 0 to Day 42 after each vaccination ]
    • Occurrence of unsolicited adverse events (AEs) [ Time Frame: From Day 0 to Day 42 after each vaccination ]
    • Occurrence of pre-specified AEs [ Time Frame: From Day 0 through study end (Day 180 or Day 222) ]
    • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From Day 0 through study end (Day 180 or Day 222) ]


    Information By: GlaxoSmithKline

    Dates:
    Date Received: February 6, 2014
    Date Started: July 2014
    Date Completion:
    Last Updated: February 24, 2017
    Last Verified: February 2017