Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
Infections, Meningococcal
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring meningococcal disease, meningitis, booster, antibody persistence
Eligibility Criteria
Inclusion Criteria:
Follow-on Participants
- Subjects from Finland and Poland previously enrolled in study V102_15 (NCT02212457) who have received all planned meningococcal vaccinations in the study
- Who have not received any additional meningococcal vaccination since the last meningococcal vaccination administered in the parent trial.
- Who have given written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
- Individuals of who the investigator believes can and will comply with the requirements of the protocol.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Naive Group
- Male and female individuals of similar age (approximately 12-20 years) to follow-on subjects from V102_15 (NCT02212457) trial.
- Who have not received any meningococcal vaccination since birth
- Individuals who have given their written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
- Individuals of who the investigator believes can and will comply with the requirements of the protocol.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria:
Follow-on Participants:
- Follow-on individuals not eligible to be enrolled in the study are those with:
- History of any meningococcal vaccine administration since last meningococcal vaccination administered in V102_15 (NCT02212457) parent study.
- Current or previous, confirmed or suspected disease caused by N. meningitidis, since termination from parent study.
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
- If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
- Pregnancy or breast-feeding
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
- Progressive, unstable or uncontrolled clinical conditions.
- Any confirmed or suspected condition with impaired/altered function of immune system.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/day. Inhaled, intranasal and topical steroids are allowed).
- Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the 3 months prior to study enrolment.
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
- Administration of any vaccine within 14 days or 28 days prior to enrollment in the study, or within 7 days after vaccination in the study.
- Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
- Who have received systemic antibiotic treatment within 3 days prior to any blood draw
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Naive Individuals
- Naive individuals not eligible to be enrolled in the study are those with:
- History of any meningococcal vaccine administration since birth.
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
- If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
- Pregnancy or breast-feeding.
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
- Progressive, unstable or uncontrolled clinical conditions.
- Any confirmed or suspected condition with impaired/altered function of immune system.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to the study enrolment. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/kg/day. Inhaled, intranasal and topical steroids are allowed).
- Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
- Individuals who are part of study personnel or close family members conducting this study.
- Administration of any vaccine within 14 days or 28 days prior to enrollment in the study, or within 7 days after first vaccination, and/or planned use of any vaccine 7 days prior to and 7 days after second vaccination.
- Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
- Who have received systemic antibiotic treatment within 3 days prior to any blood draw
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
ABCWY_ 0_2 Group
ABCWY_0_2_6 Group
B_0_2 Group
ABCWY_ 0_6 Group
ABCWY Naive Group
rMenB+OMV Naive Group
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study