E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
An open-label extension study in subjects who previously participated and completed Study V72P13. Subjects will be assigned to receive either a fourth dose of rMenB+OMV NZ, or one or two-dose catch-up regimens of rMenB+OMV NZ according to whether they received three doses of rMenB+OMV NZ with routine vaccinations or routine vaccinations only as infants in V72P13. Subjects will be recruited from the same sites as in V72P13 in Europe |
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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 |
Demonstration of a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ administered at 12 months of age, either with or without concomitant MMRV vaccination, to toddlers previously primed with three doses of rMenB+OMV NZ as infants in Study V72P13. The immune response will be assessed by the percentage of subjects with serum bactericidal assay (SBA) titers ≥ 1:5 at one month after the fourth dose, directed against N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99. The primary criterion to determine a sufficient immune response is that for the percentage of subjects with SBA titers >= 1:5 the lower limit of the two-sided 95% CI is ≥ 75% for all three reference strains. |
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E.2.2 | Secondary objectives of the trial |
-Demonstration that the immune responses to MMRV vaccination, when administered concomitantly with the fourth (booster) dose of rMenB+OMV NZ at 12 months of age, are not inferior to the immune responses of MMRV when given alone. -Assessment of the immune response following a fourth (booster) dose of rMenB+OMV NZ administered at 12 months of age, either with or without concomitant MMRV vaccination. -Evaluation of the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) in infants who previously received three doses of rMenB+OMV NZ as infants in Study V72P13 -Demonstration of the induction of immunological memory in infants who previously received three doses of rMenB+OMV NZ -Evaluation of the immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months or 12 and 14 months to naïve toddlers -Characterization of the immune response against vaccine antigen 287-953 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained. Subjects eligible to be enrolled in the study should comply with the following criteria: 1. healthy 12-month-old toddlers (0/ +59days) who completed Study V72P13; 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. |
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E.4 | Principal exclusion criteria |
1. Previous ascertained or suspected disease caused by N. meningitidis; 2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 3. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 4. Significant acute or chronic infection within the previous 7 days or axillary temperature ≥ 38°C within the previous day; 5. Antibiotics within 6 days prior to enrollment; 6. 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); 7. 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; 8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 9. Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment. 10. Participation in a clinical trial other than Study V72P13 since birth or planned for during this extension study; 11. Family members and household members of research staff; 12. 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 to determine a sufficient immune response is that for the percentage of subjects with SBA titers ≥ 1:5 the lower limit of the two-sided 95% CI is ≥ 75% for each of the three serogroup B 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 | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunogenicity, tolerability |
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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) | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Subjects randomized to the blinded part of the parent V72P13 study will remain blinded in V72P13E1 |
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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.8.2.3.1 | Comparator description |
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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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 56 |
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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 12 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |