Clinical Trial: Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

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

Official Title: Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

Brief Summary: This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values [ Time Frame: At 42 days post-vaccination ]

Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.


Original Primary Outcome: Seroconversion rates for measles, mumps, rubella and varicella [ Time Frame: approximately 42-56 days after vaccination ]

Current Secondary Outcome:

  • Antibody Concentrations Against Measles [ Time Frame: At 42-days post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
  • Antibody Concentrations Against Mumps [ Time Frame: At 42-days post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).
  • Antibody Concentrations Against Rubella [ Time Frame: At 42-days post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
  • Antibody Titers Against Varicela Viruses [ Time Frame: At 42-days post-vaccination ]
    Antibody titers were presented as geometric mean titers (GMTs).
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within the 43-day (Days 0-42) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 up to Day 43/57) ]
    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.


Original Secondary Outcome:

  • Measles, mumps, rubella and varicella antibody titres [ Time Frame: 42-56 days after vaccination ]
  • Occurrence of solicited local symptoms (injection site redness, pain and swelling) [ Time Frame: within four days after vaccination (Day 0-3) ]
  • Occurrence of solicited general symptoms in terms of fever, rash, any sign of meningitis including febrile convulsion and parotitis [ Time Frame: within 43 days after each vaccination (Day 0-42) ]
  • Occurrence of unsolicited symptoms [ Time Frame: within 43 days after vaccination (Day 0-42) ]
  • Occurrence of serious adverse events [ Time Frame: from the study vaccine dose up to study end ]


Information By: GlaxoSmithKline

Dates:
Date Received: September 10, 2008
Date Started: October 2008
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017