Clinical Trial: Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

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

Official Title: Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

Brief Summary:

This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.

A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies greater than or equal to (≥) the cut-off value. [ Time Frame: At 42-56 days after the first dose of study vaccine (Week 6) ]

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

Current Secondary Outcome:

• Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies ≥ the cut-off value. [ Time Frame: At 42-56 days after the second dose of study vaccine (Week 18) ]
  Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
• Antibody titers against measles, mumps, rubella and varicella viruses [ Time Frame: At 42-56 days after the first and second dose of study vaccine(s). ]
  Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.
• Number of subjects reporting any and grade 3 solicited local symptoms [ Time Frame: Within 4 days after each vaccination (Days 0-3) ]
  Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/ spontaneously painful. Grade 3 redness/ swelling = redness/ swelling spreading beyond 20 millimeters (mm) of injection site.
• Number of subjects reporting any and grade 3 solicited general symptoms [ Time Frame: Within 43 days (Days 0-42) after each vaccination ]
  Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.
• Number of subjects reporting any, grade 3 and related fever [ Time Frame: Within 43 days (Days 0-42) after each vaccination ]
  Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.
• Number of subjects reporting any (local or general), grade 3 and related rashes [ Time Frame: Within 43 days (Days 0-42) after each vaccination ]
  Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.
• Number of subjects reporting any, grade 3 and related unsolicited adverse event (AEs) [ Time Frame: Within 43 days (Days 0-42) after first vaccination dose ]
  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. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
• Number of subjects reporting any, grade 3 and related unsolicited adverse event (AEs) [ Time Frame: Within 43 days (Days 86-128) after second vaccination dose ]
  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. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
• Number of subjects with serious adverse events (SAEs) [ Time Frame: From first study dose (Day 0) until study end (Week 18) ]
  Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.

Original Secondary Outcome:

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

Dates:
Date Received: May 4, 2009
Date Started: June 3, 2009
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017