The purpose of this study was to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which serves for the development, qualification, validation, and maintenance of immunological assays which supports the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the two vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during their participation in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,021
Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.
One dose of MenACWY vaccine were administered intramuscularly at Day 1.
GSK Investigational Site
Sydney, New South Wales, Australia
GSK Investigational Site
Adelaide, South Australia, Australia
GSK Investigational Site
Geelong, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Spearwood, Western Australia, Australia
GSK Investigational Site
Würzburg, Bavaria, Germany
Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day -83, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.
Time frame: At Day -83 [83 days before first vaccination (Day 1)]
Number of Human Blood Samples Collected for Conversion Into Serum at Day 8
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 8, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.
Time frame: At Day 8
Number of Human Blood Samples Collected for Conversion Into Serum at Day 98
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 98, blood samples were collected only for rMenB+OMV NZ group.
Time frame: At Day 98
Number of Human Blood Samples Collected for Conversion Into Serum at Day 151
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 151, blood samples were collected only for MenACWY 1, 2 and 3 group.
Time frame: At Day 151
Number of Human Blood Samples Collected for Conversion Into Serum at Day -60
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day -60, blood samples were collected only for MenACWY 2 group.
Time frame: At Day -60 [60 days before first vaccination (Day 1)]
Number of Human Blood Samples Collected for Conversion Into Serum at Day 31
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 31, blood samples were collected only for MenACWY 2 group.
Time frame: At Day 31
Number of Human Blood Samples Collected for Conversion Into Serum at Day-30
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day -30, blood samples were collected only for MenACWY 3 group.
Time frame: At Day -30 [30 days before first vaccination (Day 1)]
Number of Human Blood Samples Collected for Conversion Into Serum at Day 61
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 61, blood samples were collected only for MenACWY 3 group.
Time frame: At Day 61
Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity in a subject or is a congenital anomaly/ birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician. Related=AE assessed by the investigator as related to the vaccination.
Time frame: Throughout the study period (approximately 4 years)
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