E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine (rMenB + OMV NZ) in order to optimize its safety profile while maintaining sufficient immunogenicity. In addition, this study will assess whether prophylactic administration of paracetamol can decrease the incidence of febrile reactions following vaccination without impacting the immunogenicity of rMenB |
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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: To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Groups I-VI and VIII) induce sufficient immune response when given to healthy infants at 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:5, at 1 month after the third vaccination. Safety: To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI; Group VIII) will reduce the incidence of fever ≥ 38.5 C (rectal)occurring within 3 days (day 1 3) following first vaccination as compared to rMenB+OMV NZ (Group I). |
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E.2.2 | Secondary objectives of the trial |
-To assess the immune response of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Groups I-VI and VIII) as measured by SBA geometric mean titers (GMTs) titer, at 1 month after the third vaccination. -To compare the immune response of rMenB+OMV NZ and of routine infant vaccines given with or without prophylactic antipyretic treatment (Group I, Group VIII) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg; 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 and for whom a parent/legal guardian is willing/able to comply with all protocol requirements; 4. In good health as determined by medical history, physical examination and clinical judgment of the investigator. |
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E.4 | Principal exclusion criteria |
1. History of any meningococcal B or C vaccine administration; 2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens; 3. Previous or current ascertained or suspected disease caused by N. meningitidis; 4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. Significant acute or chronic infection within the previous 7 days or temperature ≥ 38C within the previous day; 7. Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw; 8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9. Known or suspected impairment/alteration of the immune system resulting from (for example): a. Receipt of any immunosuppressive therapy at any time since birth b. Receipt of immunostimulants at any time since birth c. Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth; 10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 11. Receipt of, or intent to immunize with any other licensed vaccine(s) (with the exception of Rotavirus vaccines), from 28 days prior to enrollment to 28 days after the last study vaccination; 12. Receipt of any antipyretic medication in the previous 6 hours; 13. Participation in another clinical trial since birth or throughout study period; 14. Family members and household members of research staff; 15. Who have any history of seizure (one febrile seizure is not a reason for exclusion); |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity: - percentage of subjects with SBA titer ≥ 1:5 to N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99 at one month after third vaccination. Safety: The percentage of subjects with fever ≥ 38.5 C (rectal temperature) within 3 days (day 1-3) after first 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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 |
Valutare la sicurezza e limmunogenicita` di differenti dosi e formulazioni |
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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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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 | Yes |
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 | 2 |
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 | 2 |