E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Infections, Meningococcal) |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
•To assess serum bactericidal activity at approximately 4 to 7.5 years following a 2 dose primary series (persistence) compared to serum bactericidal activity at baseline in vaccination-naïve subjects
•To assess and compare the safety and tolerability of a single dose (booster) of rMenB+OMV NZ administered to follow-on subjects approximately 4 to 7.5 years after a 2 dose primary series.
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E.2.2 | Secondary objectives of the trial |
•To assess the immune response at 1 month after a third dose (booster) of rMenB+OMV NZ administered to follow-on subjects approximately 4 to 7.5 years after a 2 dose primary series, compared to the immune response at 1 month after the first dose of rMenB+OMV NZ administered to naïve subjects according to a 0, 1-month schedule
•To assess and compare the changes over time in the immune response (kinetics) at 3, 7 and 30 days after a third dose (booster) of rMenB+OMV NZ administered to follow-on subjects approximately 4 to 7.5 years after a 2 dose primary series, with that at 3, 7 and 30 days after the second dose of rMenB+OMV NZ administered to naïve subjects according to a 0,1-month schedule
•To assess the immune response at 1 month after the second dose (primary series) of rMenB+OMV NZ administered to naïve subjects according to a 0,1-month schedule. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criterion for follow-on subjects:
•Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
Inclusion Criterion for naïve subjects:
•Individuals of 15 through 21 years of age on the day of in-formed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72_41.
•17 through 24 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72P10.
Inclusion Criteria for all subjects:
•Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
•Individuals who can comply with study procedures including follow-up.
•Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method .
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E.4 | Principal exclusion criteria |
Exclusion Criterion for follow-on subjects:
•Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
Exclusion Criterion for naïve subjects:
•Received any other Meningococcal group B vaccines prior to enrolment in this study.
Exclusion Criteria for all subjects:
•Progressive, unstable or uncontrolled clinical conditions.
•Hypersensitivity, including allergy, to any component of vac-cines or medical equipment whose use is foreseen in this study.
•Abnormal function of the immune system.
•Received immunoglobulins or any blood products within 180 days prior to informed consent and assent as applicable (ac-cording to the subject’s age).
•Received an investigational or non-registered medicinal product within 30 days prior to informed consent and assent as applicable (according to the subject’s age).
•Study personnel as an immediate family or household mem-ber.
•Any other clinical condition that, in the opinion of the investi-gator, might pose additional risk to the subject due to partici-pation in the study.
•Positive results at the urine pregnancy test performed before study vaccination.
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E.5 End points |
E.5.1 | Primary end point(s) |
A) The frequencies and percentage of subjects with solicited local (i.e., injection site pain, erythema, swelling, induration) and systemic (i.e., fever [temperature ≥ 38.0°C], high fever [temperature ≥ 39.5°C], nausea, fatigue, myalgia, arthralgia, headache) AEs.
B) The frequencies and percentages of subjects with any unsolicited adverse events (AEs).
C) The frequencies and percentage of subjects with any serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs.
D) Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 in follow on and naive subjects.
E) hSBA GMT in follow on and naive subjects.
F) Geometric mean ratios (GMRs) of GMTs pre-vaccination versus 1 month after last vaccine dose in parent studies.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
A) 7 days (including the day of vaccination) after each vaccination.
B) 30 days (including the day of vaccination) after each vaccination.
C) average of 1 Months (up to 30 days ) after last dose (booster for follow on subjects and second dose for naive subjects).
D) baseline (pre-booster in follow on subjects and and pre first dose in naive subjects)
E) baseline (pre-booster in follow on subjects and and pre first dose in naive subjects)
F) pre-vaccination versus 1 month after last vaccine dose in parent studies |
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E.5.2 | Secondary end point(s) |
A) Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 and hSBA GMTs in follow on and naive subjects.
B) GMRs of GMTs of one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose versus pre-first dose (naïve subjects).
C) Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 and hSBA GMTs in follow on and naive subjects.
D) GMRs of GMTs post-vaccination with a booster dose (follow on subjects) versus pre-booster dose or second dose (naive subjects) versus pre-second dose.
E) Percentage of subjects with 4-fold rise pre-compared to three, seven, thirty days post-vaccination with a booster dose (follow-on subjects) or second dose (naive subjects) of rMenB+OMV NZ, to each and any one, two, three or all four indicator strains
F)Percentage of subjects with hSBA ≥1:5, hSBA ≥1:8, hSBA ≥1:16 and hSBA GMTs in naive subjects after 2 doses.
G) GMRs of GMTs in naive subjects after the second dose versus pre-vaccination.
H) Percentage of subjects with 4-fold rise pre-vaccination with a first dose compared to one month post-vaccination with a second dose (naïve subjects) to each and any one, two, three or all 4 indicator strains. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
A) baseline (pre-boost) and 1 month after booster (follow-on subjects), baseline (pre first dose) and 1 month after first dose (naïve subjects)
B) one month post-booster dose versus pre-booster dose (follow-on subjects), first dose versus pre-first dose (naïve subjects)
C)+ D) +E) pre-booster and three, seven, thirty days after booster dose (follow-on subjects), 1 month after first dose and three, seven, thirty days after second dose (naive subjects)
F) baseline (pre-fisrt dose)and one month after 2 doses in naive subjects
G) one month post second dose versus pre-first dose (baseline) in naive subjects
H) baseline (pre-fisrt dose) and one months after second dose (naive subjects) |
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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 | No |
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 | Yes |
E.8.1.1 | Randomised | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Different treatment schedule in naïve subjects |
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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 |
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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
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End of 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 Visit 6 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 10 |