E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027249 |
E.1.2 | Term | Meningitis meningococcal |
|
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. |
|
E.2.2 | Secondary objectives of the trial |
-Demonst 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, as measured by SBA GMTs and percentage of subjects with SBA titers ≥ 1:5 at one month after the fourth dose of rMenB+OMV NZ,directed against N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.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,as measured by SBA GMTs and the percentage of subjects with SBA titers ≥ 1:5,directed against N.meningitidis serogroup B reference strains H44/76,NZ98/254 and 5/99. |
|
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/ +29 days) 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. |
|
E.4 | Principal exclusion criteria |
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 ≥ 38C 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. |
|
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. |
|
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 | No |
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 | No |
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) | 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
| 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 | 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
| |
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 | 3 |
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 | 3 |