| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10027202 |
| E.1.2 | Term | Meningitis bacterial |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess the persistence of bactericidal antibodies in subjects who previously received 2 or 3 doses of MenABCWY (administered according to 0, 2-, 0, 6- & 0, 2, 6-month [mth] schedules) or 2 doses of rMenB+OMV (given at a 0, 2-mth schedule), 24 mths after the last meningococcal vaccination in study V102_15 compared with baseline antibody levels in meningococcal naive subjects at enrolment, as measured by percentages of subjects with HT-hSBA titers ≥ lower limit of quantitation (LLOQ) and HT-hSBA geometric mean titers (GMTs) against N. meningitidis test strains for serogroup B, and serogroups A, C, W, and Y. |
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| E.2.2 | Secondary objectives of the trial |
Immunogenicity:
• To assess the immune response at Day 31 after a booster dose of the MenABCWY vaccine or rMenB+OMV 24 months after last vaccination in study V102_15 compared with the immune response at Day 31 after a single dose of MenABCWY or rMenB+OMV in naive subjects.
Safety:
• To evaluate safety and reactogenicity of a booster dose (24 mths after last meningococcal vaccination in study V102_15), of MenABCWY in subjects who previously received 2 or 3 doses of MenABCWY or 2 doses of rMenB+OMV, and after a first dose of MenABCWY or rMenB+OMV in naïve subjects.
• To evaluate safety and reactogenicity of 2 doses of MenABCWY or rMenB+OMV in naive subjects.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Follow-on Participants
• Subjects from Finland and Poland previously enrolled in study V102_15 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 (as applicable) 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 (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
• 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 trial.
• Who have not received any meningococcal vaccination since birth
• Individuals who have given their written informed consent or assent (as applicable) 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 (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
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| E.4 | Principal exclusion criteria |
Follow-on Participants:
• History of any meningococcal vaccine administration since last meningococcalvaccination administered in V102_15 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 (immunodeficient or autoimmune conditions).
• Chronic administration (defined as more than 14 days) 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 (for inactivated vaccines) or 28 days (for live vaccines) 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
• 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 methods1 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 (immunodeficient or autoimmune conditions).
• Chronic administration (defined as more than 5 days) 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 (for inactivated vaccines) or 28 days (for live vaccines) 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.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
• Percentages of subjects with HR-hSBA titers ≥ LLOQ against each of four serogroup B test strains (M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA) and M07-0241084 (NHBA)), and serogroups A, C, W and Y (only for MenABCWY groups)
• HT-hSBA GMTs against each of four serogroup B test strains (M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA) and M07-0241084 (NHBA)), and against N.meningitidis serogroups A, C, W and Y (only for MenABCWY groups) |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At 24 months after the last meningococcal vaccination in V102_15 (NCT02212457); (follow-on subjects) and Day 1 (naive subjects) |
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| E.5.2 | Secondary end point(s) |
Secondary Immunogenicity Endpoints:
• Percentages of subjects with HT-hSBA titers ≥ LLOQ and differences between groups against each of four serogroup B test strains (M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA) and M07-0241084 (NHBA)), and serogroups A, C, W and Y (only after MenABCWY vaccination)
• HT-hSBA GMTs and between group ratios against each of four serogroup B test strains (M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA) and M07-0241084 (NHBA)), and serogroups A, C, W and Y (only after MenABCWY vaccination)
• Percentages of subjects with four-fold rise in HT-hSBA titers and group differences, against each of four serogroup B test strains (M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA)), and serogroups A, C, W and Y (only after MenABCWY vaccination). Four-fold rise is defined as follows: for subjects with prevaccination titers > LLOQ, a post vaccination hSBA ≥ 4 times the LLOQ; for subjects with prevaccination hSBA titers ≥ LLOQ, an increase of at least 4 times the prevaccination hSBA
Secondary Safety Endpoints:
• Number of subjects reporting any solicited AEs within 30 minutes after vaccination
• Number of subjects reporting any unsolicited AEs within 30 minutes after vaccination
• Number of subjects reporting solicited local and systemic AEs
• Number of subjects reporting other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) within 7 days after vaccination
• Number of subjects reporting unsolicited AEs
• Number of subjects reporting medically-attended AEs
• Number of subjects reporting AEs leading to premature withdrawal from the study
• Number of subjects reporting serious adverse events (SAEs) |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity:
At Days 1 (except four-fold rise), 6 and 31 for follow-on subjects, and at Days 1, 31, 66, and 91 for naive subjects
Safety (Adverse Events / Serious Adverse Events):
• Follow-on group: Days 1, 16, 31, 91 and 181
• Naïve group: Days 1, 31, 66, 91 and 241 |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Long term antibody persistence and booster response |
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| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| for some objectives the vaccine naïve group is acting as control |
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| E.8.2.4 | Number of treatment arms in the trial | 6 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 18 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| The date of the last testing/reading released of human biological samples or imaging data, related to primary and secondary end points, to be achieved no later than 8 months after Last Subject Last Visit (LSLV). |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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