E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B, A fourth (booster) dose of rMenB+OMV NZ is used to evaluate safety tollerbility and immunogenicity and exploring the bactericidal antibody persistence at 12, 18 and 24 months of age. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers to generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen |
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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 |
To demonstrate a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ in at least one of the time points, when given at 12, 18 or 24 months of age to toddlers previously primed with three doses of rMenB+OMV NZ as infants at 2, 4 and 6 months of age (with concomitant routine vaccines). |
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E.2.2 | Secondary objectives of the trial |
a.Sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ in at least one of the time points, when given at 12, 18 or 24 months of age to toddlers previously primed. b.Characterize the immune response following a fourth (booster) dose of rMenB+OMV NZ, when given at 12, 18 or 24 months of age to toddlers previously primed. c.Assess the immune response one month after a fourth (booster) dose of rMenB+OMV NZ given at 12, 18 or 24 months of age to toddlers previously primed. d.Characterize bactericidal antibody persistence in 12,18 and 24month-old toddlers previously primed. e.Characterize the induction of immunological memory in toddlers previously primed. f.Assess the immunogenicity of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months. g-Characterize the immune response against vaccine antigen 287-953 one month after the fourth (booster) dose -Safety and tolerability of a fourth dose and of of a two-dose catch-up regimen. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Group 5: healthy 18-month-old toddlers (0/ +29 days window); Group 6: healthy 24-month-old toddlers (0/ +29 days window); 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 Inclusion Criteria for follow-on participants (Groups 1, 2, 3 and 4): Inclusion criteria are the same as for Groups 5 and 6, with the addition that are subjects: 1. who participated and completed V72P12 study 2. who are aged: o 12 months or older - Groups 1a, 2a, 3a, 4 o 18 months (0/ +29 days window) - Groups 1b, 2b, 3b) o 24 months (0/ +29 days window) - Groups 1c, 2c, 3c) |
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E.4 | Principal exclusion criteria |
1. subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2. history of any meningococcal B vaccine administration; 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 axillary temperature ≥ 38°C within the previous day; 7. antibiotics within 7 days prior to enrollment; 8. any serious chronic or progressive disease 9. known or suspected impairment/alteration of the immune system10. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation receipt of, or intent to immunize with any other vaccine(s), within 30 days prior to enrollment; 12. participation in another clinical trial within 90 days prior to enrolment 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary criterion for immunogenicity following the fourth dose of rMenB+OMV NZ is that the lower limit of the two-sided 98.3% CI for the percentage of subjects with SBA titers ≥ 1:5 at one month following the fourth vaccination is ≥ 75% for all three reference strains. The power for this primary endpoint is > 99%, assuming 180 evaluable subjects per group and at least 90% of the subjects showing SBA titers ≥ 1:5 after four doses of rMenB OMV NZ for each of the three strains. If there are only 100 evaluable subjects per group the overall power will be 85%, assuming at least 90% of the subjects showing SBA titer ≥ 1:5 after four doses of rMenB OMV NZ for each of the three reference 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 | Yes |
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 |
tollerability and immunogenicity |
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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 | Yes |
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) | 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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 25 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |