| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Prevent invasive disease caused by the bacterium Neisseria meningitidis serogroup B |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 17.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10004049 |
| E.1.2 | Term | Bacterial meningitis |
| E.1.2 | System Organ Class | 100000004862 |
|
| 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 immunogenicity of 60 mcg, 120 mcg, and 200 mcg rLP2086 vaccine as measured by SBA performed with MnB strains expressing LP2086 subfamily A and B proteins in healthy adolescents aged 11 to 18 years. |
|
| E.2.2 | Secondary objectives of the trial |
| To assess the immunogenicity of 60 mcg, 120 mcg, and 200 mcg rLP2086 vaccine as determined by quantitation of immunoglobulin (Ig) binding to rLP2086 vaccine subfamily A and B proteins in healthy adolescents aged 11 to 18 years. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Stage 1:
1. Male or female subjects between the ages of ≥11 and ≤18 years at the time of enrollment.
2. Healthy male or female subjects as determined by medical history and physical examination.
3. Negative urine pregnancy test for all female subjects.
4. All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of hormonal and/or nonhormonal contraception during the 6-month vaccination period and for 30 days after the final vaccination or early discontinuation of the study. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
5. arent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
Stage 2:
1. Healthy male or female subjects as determined by medical history and physical examination.
2. Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
|
|
| E.4 | Principal exclusion criteria |
Stage 1:
1. Pregnant or breastfeeding women.
2. Receipt of any vaccination with a serogroup B meningococcal vaccine at any time prior to the administration of the first dose of test article.
3. History of any invasive meningococcal disease.
4. A previous anaphylactic or severe vaccine-associated adverse reaction.
5. A known hypersensitivity to any study vaccine components.
6. Any clinically significant chronic disease.
7. A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
8. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular (IM) injection.
9. Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
10. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
11. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response.
12. Subject is a direct descendant (child or grandchild) of the study site personnel.
Stage 2:
1. Receipt of any vaccination with a serogroup B meningococcal vaccine at any time prior to the administration of the first dose of test article.
2. History of any invasive meningococcal disease.
3. Any clinically significant chronic disease.
4. A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular (IM) injection.
6. Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
7. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
8. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response.
9. Subject is a direct descendant (child or grandchild) of the study site personnel. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary immunological endpoint is the seroconversion rate of rLP2086 specific SBA titers to 1 subfamily A strain and 1 subfamily B strain after postdose 2 and postdose 3 in subjects receiving the dose levels selected for the full enrollment phase. Seroconversion is defined as a 4 fold rise in rLP2086 specific SBA titers from predose 1. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| 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 | No |
| 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 |
| Tolerability and immunogenicity |
|
| 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 | No |
| E.8.1.3 | Single blind | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| 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 | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| 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
|
| The end of the study is the last visit of the last subject. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 6 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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