The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
302
Two doses of the MenABCWY vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, on a 0-, 24-month schedule in the ABCWY-24 Group, and a 0-, 48-month schedule in the ABCWY-48 Group.
Single dose of Placebo (saline solution in pre-filled syringe), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1441 in the ABCWY-24 Group, and at Day 721 in the ABCWY-48 Group.
Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains
The immune response to 2 doses of the MenABCWY vaccine administered on a 0-, 24-month schedule, and a 0-, 48-month schedule is evaluated against each N. meningitidis serogroup B indicator strains.
Time frame: At Baseline (Day 1)
Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains
The immune response to 2 doses of the MenABCWY vaccine administered on a 0-, 24-month schedule, and a 0-, 48-month schedule is evaluated against each N. meningitidis serogroup B indicator strains.
Time frame: At 1 month after the second dose of MenABCWY (Day 751 for the ABCWY-24 Group and Day 1471 for the ABCWY-48 Group)
Percentage of participants with solicited administration site events
The solicited administration site events include pain, redness, swelling and induration. Redness, swelling, and induration are summarized according to defined severity grading scales: None (0 to 24mm); Mild (25 to 50mm); Moderate (51 to 100mm); Severe (\>100mm). Injection site pain is summarized according to "mild", "moderate" or "severe".
Time frame: During the 7 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)
Percentage of participants with solicited systemic events
The solicited systemic events include fever, headache, nausea, myalgia, arthralgia and fatigue. Fever is defined as body temperature 38.0°C (100.4°F). The preferred location for measuring temperature in this study is the oral route. Solicited systemic events (except fever) are summarized according to "mild", "moderate" or "severe".
Time frame: During the 7 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)
Percentage of participants with any unsolicited adverse events (AEs) including all serious adverse events (SAEs), AEs leading to withdrawal, adverse events of special interest (AESIs) and medically attended AEs
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Ventura, California, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Macon, Georgia, United States
GSK Investigational Site
Valparaiso, Indiana, United States
GSK Investigational Site
Nicholasville, Kentucky, United States
GSK Investigational Site
Haughton, Louisiana, United States
...and 20 more locations
An unsolicited AE is an AE that was not included in a list of solicited events and must have been spontaneously communicated by a participant/participant's parent(s)/ Legally Acceptable Representative(s) who has signed the informed consent. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or is an abnormal pregnancy outcome. AESIs are predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring a hospitalisation, or an emergency room visit, or visit to/by a health care provider.
Time frame: During the 30 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441)
Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or is an abnormal pregnancy outcome. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring a hospitalisation, or an emergency room visit, or visit to/by a health care provider.
Time frame: During the 6 months (including the day of vaccination) following the first vaccination (Vaccine administered at Day 1)
Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or is an abnormal pregnancy outcome. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring a hospitalisation, or an emergency room visit, or visit to/by a health care provider.
Time frame: During the 6 months (including the day of vaccination) following the second vaccination (Vaccine administered at Day 721)
Percentage of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y
The immune response to 1 and 2 doses of the MenABCWY vaccine administered on a 0-, 24-month schedule, and a 0-, 48-month schedule is evaluated against N. meningitidis serogroups A, C, W and Y.
Time frame: At Baseline (Day 1), 1 month after the first dose of MenABCWY (Day 31) and 1 month after second dose of MenABCWY (Day 751 for the ABCWY-24 Group and Day 1471 for the ABCWY-48 Group)
Percentage of participants with hSBA titers ≥ LLOQ for each N. meningitidis serogroup B indicator strains and for serogroups A, C, W and Y
The antibody persistence at 25 months after the second dose of the MenABCWY vaccine administered on a 0-, 24-month schedule is evaluated against each N. meningitidis serogroup B indicator strains and serogroups A, C, W and Y.
Time frame: At 25 months after the second dose of MenABCWY (Day 1471 for the ABCWY-24 Group)