E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Meningococcal Group B disease. |
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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 | 17.0 |
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 |
Primary Immunogenicity Objective
Establish a control sera panel using pre- and post-vaccination blood donations to be used as a reference in SBA tests
Primary Safety Objective
To assess the safety of two doses of rMenB+OMV NZ in healthy adult subjects |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Individuals of 18 through 50 of age on the day of informed consent.
2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who can comply with study procedures including follow-up*.
4. Males
Or
Females of non-childbearing potential*
Or
Females of childbearing potential who are using an effective birth control method* which they intend to use for at least 30 days after the last study vaccination.
Prior to receipt of the second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.
*Please refer to the footnote of the protocol. |
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E.4 | Principal exclusion criteria |
Each subject must not have:
1. Progressive, unstable or uncontrolled clinical conditions.
2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study.
3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
4. Body weight ≤ 50 Kg at the time of informed consent
5. Abnormal function of the immune system resulting from:
a. Clinical conditions.
b. Systemic administration of corticosteroids (PO/IV/IM) at any dose and for any duration within 90 days prior to informed consent.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy at any dose and for any duration within 90 days prior to informed consent.
6. Received immunoglobulins or any blood products at any dose and for any duration from 3 months prior to informed consent.
7. Must not have chronic clinical significant conditions
8. Received an investigational or non-registered medicinal product within 30 days prior to informed consent
9. Study personnel as an immediate family or household member
10. Been administered any group B meningococcal vaccine at any time prior to informed consent.
11. Current or previous, confirmed or suspected disease caused by N. meningitidis.
12. Tested positive at the baseline pregnancy test.
13. Nursing (breastfeeding) mothers;
14. Any clinical condition manifesting in abnormal metabolic, hematological or cardiocirculatory measurements, including conditions which would so manifest if left untreated.
15. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Prior to receipt of the second administration of the study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects meet any of the original exclusion criteria listed above, they should not receive additional vaccinations. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Safety Endpoint(s)
Safety of the study vaccines will be assessed in all subjects in terms of the frequency of reported adverse events including:
- Any unsolicited AEs reported within 30 minutes after each vaccination;
- Medically-attended AEs reported during the entire study period;
- AEs leading to premature withdrawal from the study during the entire study period;
- SAEs reported during the entire study period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The study comprises four clinical visits (pre-vaccination, Day 1, Day 61, and Day 91).
The pre-vaccination and Day 1visits may be combined.
All subjects will undergo 2 blood donations. Blood (approximately 150 mL) will be drawn from all subjects before first vaccination (Day 1) and 1 month after the second vaccination (Day 91).
Vaccinations will be given to all subjects at Day 1 and Day 61 (Visits 1 and 2).
Subjects will be observed for at least 30 minutes after each vaccination for any immediate reactions. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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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End of study is defined as the completion of the 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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |