| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Prophylaxis of meningococcal meningitiditis caused by Neisseria meningitidis bacterium, serogroup B |
|
| E.1.1.1 | Medical condition in easily understood language |
| Prevention of meningococcal B disease |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| 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 |
1. To demonstrate the sufficiency of the immune response to rMenB+OMV NZ vaccine, when given concomitantly with routine vaccines (i.e DTaP-IPV-Hib, HepB and PCV-13) to healthy infants at 2, 4, 6 months of age as measured by percentage of subjects with human serum bactericidal activity (h-SBA) titer ≥ 1:5 against the indicator strains H44/76, 5/99 and NZ98/254 at 1 month after the third vaccination (at 7 months of age);
2. To assess the safety of a 3-dose schedule (at 2, 4, 6 months) of Novartis Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants;
3. To assess serious adverse events, medically attended AEs, AEs leading to withdrawal from the study throughout the entire study. |
|
| E.2.2 | Secondary objectives of the trial |
1.To demonstrate the sufficiency of the immune response to a booster dose of rMenB+OMV NZ vaccine when given concomitantly with routine vaccines (MMR and varicella) to healthy toddlers at 12 months of age,previously primed with 3-doses of rMenB+OMV NZ, as measured by percentage of subjects with h-SBA titer ≥ 1:5 against strains H44/76, 5/99 and NZ98/254 at 1 month after the booster dose (13 months age).
2. To assess bactericidal antibodies against meningococcal B in healthy infants receiving rMenB+OMV NZ concomitantly with routine vaccines or routine vaccines alone at 2, 4, 6 and 12 months age, as measured by SBA geometric mean titers (GMTs), and geometric mean ratios (GMRs) between post/prevaccination titers and percentage of subjects with h-SBA titer ≥ 1:5 against strains H44/76, 5/99, NZ98/254, M10713 at baseline (2 months age), 1 month after the third vaccination (7 months of age), prior to the booster dose (12 months age) and at 1 month after the booster dose (13 months age). |
|
| 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;
4. In good health as determined by medical history, physical examination and clinical judgment of the investigator. |
|
| E.4 | Principal exclusion criteria |
1. History of any meningococcal vaccine administration;
2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), Pneumococcal, MMR (Measles, Mumps, Rubella) or varicella antigens;
3. Previous 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 body temperature higher or equal to 38 C degrees within the previous day;
7. Antibiotics within 6 days prior to enrollment;
8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin dependent 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, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids 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 vaccine(s) (with the exception of rotavirus vaccine, influenza vaccine and second HepB vaccine), within 28 days prior and throughout the study period. Furthermore, subjects must have received HepB vaccine preferably at 0, 1 month of age, with the second dose at least 14 days prior to study vaccination. Influenza vaccine should be administered at least 14 days before or 14 days after study vaccination; Rotavirus vaccine may be administered during the study as per local practice.
12. Participation in another clinical trial since birth or planned for during study;
13. Family members and household members of research staff;
14. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Immunogenicity: percentage of subjects with human Serum Bactericidal Activity (h-SBA) titer ≥ 1:5 against the indicator strains H44/76, 5/99 and NZ98/254.
2. Safety: assess the percentage and numbers of subjects with local and systemic adverse events (AEs).
3. Safety: assess the percentage of subjects with serious adverse events, medically attended AEs and AEs leading to premature study withdrawal. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. One month after the third vaccination
2. Until 7 days after each vaccination
3. Throughout entire study period |
|
| E.5.2 | Secondary end point(s) |
1. Percentage of subjects with h-SBA titer ≥ 1:5 against the indicator strains H44/76, 5/99 and NZ98/254.
2. h-SBA Geometric Mean Titre (GMT) against the indicator strains H44/76, 5/99 and NZ98/254.
3. h-SBA Geometric Mean Ratio (GMR) between postvaccination and prevaccination.
4. Percentage of subjects with h-SBA titer ≥ 1:5 against the indicator strains H44/76, 5/99 , NZ98/254 and M10713. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. One month after booster dose.
2, 3, 4. Baseline (2 months of age), 1 month after the third vaccination (7 months of age); prior to the booster vaccination (12 months of age), 1 month after the booster vaccination (13 months of age).
|
|
| 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 |
|
| 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| 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
|
| The end of the study is defined as the completion of the testing of such biological samples, to be achieved no later than 8 months after collection of the last biological sample (last visit of the last enrolled subject). |
|
| E.8.9 Initial estimate of the duration of the trial |
| 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 | 9 |
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