The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.
The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
184
At 2, 3, 4, 5, 6 years after booster vaccination.
Espoo Vaccine Research Clinic
Espoo, Finland
Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
Helsinki, Finland
Helsinki East Vaccine Research Clinic
Helsinki, Finland
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 36 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 48 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 60 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 72 months after booster Vaccination
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
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Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
Jarvenpaa, Finland
Tampereen yliopisto/ Oulun rokotetutkimusklinikka
Oulu, Finland
Tampereen yliopisto/ Porin rokotetutkimusklinikka
Pori, Finland
Seinajoki Vaccine Research Clinic
Seinäjoki, Finland
Tampere Vaccine Research Clinic
Tampere, Finland
Tampereen yliopisto/ Turun rokotetutkimusklinikka
Turku, Finland
Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
Vantaa, Finland
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to the Month 72 after booster vaccination (up to 6 years)
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination