| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| no medical, condition; healthy, at risk volunteers will be recruited for a clinical trial to receive three vaccinations against meningococcal strain B and one vaccination against meningococcal strains A,C, W and Y. |
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| MedDRA Classification |
| 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 |
Immunogenicity Objectives
· To explore the immunogenicity of three doses of Novartis rMenB + OMV in healthy at risk adults, by evaluation of the breadth of serum bactericidal activity using human complement (BCA) response against a panel of genetically distinct meningococcal strains, at one month after the administration of the first, the second and the third dose and immediately before the administration of the third dose.
· |
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| E.2.2 | Secondary objectives of the trial |
To explore the immunogenicity of a single dose of Novartis MenACWY conjugate vaccine given to healthy at risk adults, by evaluation of serum bactericidal activity using human complement (BCA) response against N. meningitidis serogroups A, C, W and Y, at one month after vaccination.
Safety Objectives
· To explore the safety and tolerability of Novartis rMenB + OMV in healthy at-risk adults when administered at a 0, 2, 6- month schedule, throughout the clinical study.
· To explore the safety and tolerability of a single dose of Novartis MenACWY conjugate vaccine in healthy at-risk adults.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Individuals eligible to be enrolled into this study are those:
1. male and female adults 18 through 50 years of age at enrollment;
2. able to comprehend and follow all required study procedures;
3. who have given written consent after the nature of the study has been explained;
4. 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);
5. in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
6. who are or may be routinely exposed to N. meningitidis cultures.
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| E.4 | Principal exclusion criteria |
Individuals not eligible to be enrolled into this study are those who:
1. have had household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
2. have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (defined as axillary temperature ≥ 38°C) within the previous day;
3. have received antibiotics within 6 days prior to enrollment;
4. are pregnant or nursing (breastfeeding) mothers or females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 8-month duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
5. suffer from any serious chronic or progressive disease (e.g., any history of neoplasm, insulin dependent diabetes, cardiovascular disease, hepatic disease, renal disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, signs of cardiac or renal failure or severe malnutrition). Subjects who suffer from metabolic syndrome with more than 2 criteria fulfilled and/or not sufficiently controlled diseases as part of the metabolic syndrome will have to be excluded. (exception: subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring chronic use of inhaled or systemic corticosteroids are not eligible for enrollment);
6. have any other serious chronic disease including progressive neurological disease or seizure disorder;
7. have a known or suspected impairment/alteration of the immune system, resulting from:
· receipt of immunosuppressive therapy, including use of corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed];
· receipt of immunostimulants
8. have an inherited genetic anomaly (known cytogenic disorders, e.g., Down's Syndrome);
9. have received blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
10. have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
11. have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component;
12. have either received, or for whom there is intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period (exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment);
13. are obese at screening (e.g., with a body mass index [BMI] ≥ 30 where BMI reflects obesity and not high muscle mass);
14. have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study;
15. have a current problem or a history of substance abuse which, in the opinion of the investigator or medical monitor, might interfere with participation in the study;
16. have any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
MEASURES OF IMMUNOGENICITY:
· Bactericidal activity (% ³1:4, i.e., percentage of subjects with BCA titer ³ 1:4) against a panel of genetically distinct meningococcal B strains:
- prior to the first vaccination
- 30 days following the first, second, prior to the third and 30 days after the third vaccination
· Bactericidal activity (% ³ 1:8, i.e. percentage of subjects with BCA titer ³ 1:8) against a panel of genetically distinct meningococcal B strains:
- prior to the first vaccination
- 30 days following the first, second, prior to the third and 30 days after the third vaccination
· Bactericidal activity (four-fold rise from baseline) against a panel of genetically distinct meningococcal B strains 30 days following the first, second, prior to the third and 30 days after the third vaccination
· Bactericidal activity (geometric mean titers, geometric mean ratio to baseline) against a panel of genetically distinct meningococcal B strains prior to the first and 30 days following the first, second, prior to the third and 30 days after the third vaccination
· Bactericidal activity (% ³ 1:8, i.e. percentage of subjects with BCA titer ³ 1:8 and % ³1:4, i.e., percentage of subjects with BCA titer ³ 1:4) against N. meningitidis serogroups A, C, W-135, and Y at one month after vaccination.
· Bactericidal activity (geometric mean response, geometric mean ratio and fourfold rise to baseline) against N. meningitidis serogroups A, C, W-135, and Y at one month after vaccination.
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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 | 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) | 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 | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| 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.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 2 |
| 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 | Information not present in EudraCT |
| 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
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
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