| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Primary immunization against Neisseria meningitidis serogroups A, B, C, W-135, and Y. |
|
| E.1.1.1 | Medical condition in easily understood language |
| vaccination again bacteria Neisseria meningitidis serogroups A, B, C, W-135, and Y |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10027202 |
| E.1.2 | Term | Meningitis bacterial |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| 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 the immune response to 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY administered concomitantly in the same arm or in 2 different arms, and to a single dose of MenACWY at 1 month after the last vaccination. |
|
| E.2.2 | Secondary objectives of the trial |
Immunogenicity Objective
•To assess the immune response to 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY administered concomitantly in the same arm or in 2 different arms at 1 month after the first vaccination.
Safety Objective
•To assess the safety and tolerability of 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY administered concomitantly in the same arm or in 2 different arms, and to a single dose of MenACWY. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subjects and/or subjects’ parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the pDiary, return for follow-up visits, availability for all visits scheduled in the study).
2. Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
3. Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure.
4. A male or female between, and including, 10 to 25 years of age at the time of the first vaccination.
5. Healthy subjects as established by medical history and clinical examination before entering into the study.
6. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.
7. Female subjects of childbearing potential may be enrolled in the
study, if the subject: has practiced highly effective contraception for 30
days prior to vaccination, and has a negative pregnancy test on the day
of vaccination, and has agreed to continue highly effective contraception during the entire treatment period and for 2 months after completion of the vaccination series. |
|
| E.4 | Principal exclusion criteria |
1. Female planning to become pregnant or planning to discontinue contraceptive precautions.
2. Pregnant or lactating female.
3. Child in care.
Each subject must not have:
4. Current or previous, confirmed or suspected disease caused by N. meningitidis.
5. Known contact to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to enrollment.
6. Previous vaccination against N. meningitidis at any time prior to informed consent.
7. Progressive, unstable or uncontrolled clinical conditions.
8. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
9. Clinical conditions representing a contraindication to IM vaccination and blood draws.
10. Abnormal function of the immune system resulting from:
-Clinical conditions.
-Systemic administration of corticosteroids (oral/intravenous/IM) for more than 14 consecutive days within 90 days prior to informed consent.
-Administration of antineoplastic and immune-modulating agents or radiotherapy within 90 days prior to informed consent.
11. Received immunoglobulins or any blood products within 180 days prior to informed consent.
12. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
13. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
14. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
15. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination.
16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
17. Are obese at screening (e.g. with a body mass index [BMI] > = 30 kg/m2, where BMI reflects obesity and not high muscle mass).
18. Family history of congenital or hereditary immunodeficiency.
19. History of neuroinflammatory or autoimmune condition.
20. History of significant neurological disorder or seizure (history of febrile convulsion should not lead to exclusion).
21. Serious chronic illness.
22. History of chronic alcohol consumption and/or drug abuse (including current consumption/abuse).
23. Any study personnel as an immediate family or household member. 24. Administration of a vaccine not foreseen by the study protocol in the
period starting 14 days (for inactivated vaccines), 28 days (for live
vaccines), or 7 days (for influenza vaccines) before each dose and
ending 14 days (for inactivated vaccines), 28 days (for live vaccines), or
7 days (for influenza vaccines) after each dose of study vaccine(s)
administration.
25. Thrombocytopenia, bleeding disorders, or be receiving anticoagulant
therapy. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immune responses against N. meningitidis serogroup B* test strains and N. meningitidis serogroups A, C, W-135, and Y, as measured by hSBA, 1 month after the last vaccination in all study groups
- hSBA GMTs against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y hSBA
- GMTs against all of N. meningitidis serogroup B test strains (pooled)
- Percentage of subjects with hSBA titers ≥ the lower limit of quantitation (LLOQ) against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y
- Percentage of subjects with a 4-fold increase in hSBA titers against N. meningitidis serogroups B test strains and against N. meningitidis serogroups A, C, W-135, and Y
- hSBA geometric mean ratios (GMRs) against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y at 1 month after the last vaccination against baseline (Day 1)
*Serogroup B tests strains that will be tested are M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA), and M07-0241084 (NHBA).
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At 1 month after last vaccination |
|
| E.5.2 | Secondary end point(s) |
| To assess the immune response to 2 doses of MenABCWY, rMenB+OMV NZ, or rMenB+OMV NZ and MenACWY adminis-tered concomitantly in the same arm or in 2 different arms at 1 month after the first vaccination. |
Immune responses against N. meningitidis serogroup B* test strains and N. meningitidis serogroups A, C, W-135, and Y, as measured by hSBA, 1 month after the first vaccination in all groups (except for subjects in the MenACWY group)
- hSBA GMTs against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y
- hSBA GMTs against all of N. meningitidis serogroup B test strains (pooled)
- Percentage of subjects with hSBA titers ≥ the LLOQ against each of the N. meningitidis serogroup B test strains and against N. meningitides serogroups A, C, W-135, and Y
- Percentage of subjects with a 4-fold increase in hSBA titers against N.
meningitidis serogroups B test strains and against N. meningitidis
serogroups A, C, W-135, and Y
- hSBA GMRs against each of the N. meningitidis serogroup B test strains and against N. meningitidis serogroups A, C, W-135, and Y at 1 month after the first vaccination against baseline (Day 1)
*Serogroup B tests strains that will be tested are M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA), and M07-0241084 (NHBA).
Safety endpoints:
Solicited local and systemic AEs in all study groups
- Occurrence of solicited local and systemic AEs during the 7 days
(including the day of vaccination) after each vaccination (Day 1 to Day 7 and Day 61 to Day 67 [Day 1 to Day 7 only for subjects in the MenACWY group])
- Unsolicited AEs in all study groups
- Occurrence of unsolicited AEs during the 30 days (including the day of vaccination) after each vaccination (Day 1 to Day 31 and Day 61 to Day 91 [Day 1 to Day 31 only for subjects in the MenACWY group])
- SAEs, medically attended AEs, AEs leading to withdrawal, and AESIs, in all study groups from informed consent signature to Visit 4 (Day 91) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| At 1 month after last vaccination |
|
| 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 |
|
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 5 |
| 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 | 17 |
| E.8.5 | The trial involves multiple Member States | No |
| 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 | No |
| 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
|
| Date of the last testing results released for the samples collected at Visit 4 (Day 91), to be achieved no later than 8 months after the Last Subject Last Visit (LSLV) |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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