E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention Meningitis/Sepsi caused by Meningococcus type B or A, C, W-135, Y |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10021881 |
E.1.2 | Term | 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 |
Immunogenicity Objectives ᄋTo 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.ᄋTo 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 ᄋTo 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.ᄋTo explore the safety and tolerability of a single dose of Novartis MenACWY conjugate vacci |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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 >= 38ᄚC) 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). The criteria from number 6 to number 16 are reported in the Protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ᄋ 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.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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |