E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The Novartis Meningococcal B Recombinant +/- OMV Vaccine is intended for prevention of meningitidis and/or septicemia cause by Neisseria menigitidis serogroup B. The objective of the Novartis Meningococcal B Recombinant +/-OMV Vaccine is to identify vaccine candidates that are safe and that provide functional immune responses against heterologus meningococcal B strains. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV when administered to healthy infants, at 30 days after the second and the third dose, by evaluation of the breadth of bactericidal activity (BCA) response against a panel of genetically distinct meningococcal strains.
To explore the safety and tolerability of Novartis rMenB with or without OMV throughout the clinical study. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. healthy 6-8 months old infants; 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. available for all the visits scheduled in the study; 4. in good health as determined by: • medical history • physical examination • clinical judgment of the investigator |
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E.4 | Principal exclusion criteria |
1. whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2. who have previously received any meningococcal B vaccine; 3. who have a previous ascertained or suspected disease caused by N. meningitidis; 4. who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 6. who have experienced fever (defined as axillary temperature ≥38.0°C) within the previous 3 days or are suffering from a present acute infection disease; 7. who have any present or suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure, hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome); 8. who have leukemia, lymphomas; 9. who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example): a. receipt of any immunosuppressive therapy b. receipt of any systemic corticosteroid or ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression (e.g., 1 mg/kg/day of prednisone [or its equivalent]) c. chronic use of inhaled high-potency corticosteroids (e.g., budesonide 800 µg per day or fluticasone 750 µg per day); 10. with a suspected or known HIV infection or HIV related disease; 11. who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study; 12. with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 13. who have experienced any seizure, either associated with fever or as part of an underlying neurological disorder or syndrome; 14. who have received antibiotics within 6 days prior to enrollment; 15. who have either received, or for whom there is intent to immunize with any other vaccine(s), with respect to the study vaccines, within 30 days prior and throughout the study period [Exception: the applicable routine immunization (e.g. MMR, MCC-Hib, PC7) are allowed]; 16. 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; 17. whose parents/legal guardians, are planning to leave the area of the study site before the end of the study period; 18. with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV when administered to healthy infants, at 30 days after the second and the third dose, by evaluation of the breadth of bactericidal activity (BCA) response against a panel of genetically distinct meningococcal strains. |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
Phase 2 Safety, Tolerability and Immunogenicity |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | 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) | 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
| 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 | 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
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The End of Trial corresponds to the last contact/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 | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |