E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive. |
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E.1.1.1 | Medical condition in easily understood language |
Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
|
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 immune response, SBA will be performed against the N. meningitidis serogroup B indicator strains H44/76, NZ98/254 and 5/99 at one month after a vaccination course of two doses of rMenB + OMV NZ administered two months apart. |
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E.2.2 | Secondary objectives of the trial |
Efficacy Objectives: Characterization of the immune response against vaccine antigen 287-953, as measured by ELISA at one month after a vaccination course of two doses of rMenB + OMV NZ administered two months apart.
Safety Objectives: To evaluate the safety and tolerability of two doses of rMenB+OMV
NZ vaccine given two months apart, in healthy at-risk adults. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 – 65 years of age inclusive who have given written informed consent at the time of enrollment;
Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
In good health as determined by medical history, physical examination and clinical judgment of the investigator;
Who are or might be routinely exposed to cultures of N. meningitidis serogroup B. |
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E.4 | Principal exclusion criteria |
Pregnancy or nursing (breastfeeding) mothers;
Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry;
Any serious chronic or progressive disease according to judgment of the investigator;
Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria;
History of any serogroup B meningococcal vaccine administration;
Previous known or suspected disease caused by N. meningitidis;
History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine;
Known or suspected autoimmune disease or impairment/alteration of the immune system;
Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;
History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
Any significant chronic infection;
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
Family members and household members of research staff;
Participation in another clinical trial within the last 30 days or planned for during
study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Refer to section 7 of the study protocol |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Refer to section 3 of the study protocol |
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E.5.2 | Secondary end point(s) |
Refer to section 7 of the study protocol |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Refer to section 3 of the study protocol |
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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 | Yes |
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
|
Last subject - last visit |
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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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |