| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (active immunization against invasive disease caused by N. meningitidis serogroups A, B, C, W and Y) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Meningitis, Invasive Meningococcal Disease |
|
| 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 demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4 fold rise in hSBA titers against N. meningitidis serogroups A, C, W, and Y, at 1 month after the first MenABCWY vaccination (0,6 months) and 1 month after the MenACWY vaccination (single dose).
• To evaluate the safety and reactogenicity of the MenABCWY and MenACWY vaccines.
|
|
| E.2.2 | Secondary objectives of the trial |
• To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A, C, W, and Y, at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose)
• To assess the immune response to MenABCWY (0,6-month schedule) and MenACWY (single dose) vaccines against N. meningitidis serogroups A, C, W, and Y, at pre-vaccination and at 1 month after the first and last MenABCWY vaccinations and 1 month after the MenACWY vaccination
• To assess the immune response to the MenABCWY vaccine (0,6-month schedule) against N. meningitidis serogroup B indicator strains, at pre-vaccination and at 1 month after the last MenABCWY vaccination
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Participants and/or participants’ parents/LARs, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits)
2. Written or witnessed/thumb printed informed consent obtained from the participant/participant’s parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
3. Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure.
4. Previous vaccination with 1 dose of MenACWY vaccine at an age of 10 years or older, with an interval of at least 4 years and not more than 6 years between the previous MenACWY vaccine and enrollment (informed consent and assent [as applicable]) into this study.
5. A male or female between, and including, 15 and 25 years of age (i.e., 25 years + 364 days) at the time of the first vaccination.
6. Healthy participants as established by medical history, physical examination, and clinical judgment of the investigator before entering into the study.
7. Female participants 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, bilateral ovariectomy, or post-menopause.
8. Female participants of childbearing potential may be enrolled in the study, if the participant:
– has practiced adequate contraception for 30 days prior to vaccination, and
– has a negative pregnancy test* on the day of vaccination, and
– has agreed to continue adequate contraception during the entire intervention period and for 30 days after completion of the vaccination series. |
|
| E.4 | Principal exclusion criteria |
1. Current or previous, confirmed or suspected disease caused by N. meningitidis.
2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrollment.
3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product.
4. Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.
5. Progressive, unstable or uncontrolled clinical conditions
6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
7. Abnormal function or modification of the immune system resulting from:
– Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
– Systemic administration of corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to study vaccination until the following post vaccination blood sample. This will mean prednisone ≥20 mg/day (for adult participants) or ≥0.5 mg/kg/day or ≥20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
– Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
– Administration of long-acting immune-modifying drugs at any time during the study period
8. Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.
9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
10. Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study vaccine(s)/product during the period beginning 30 days before the first dose of study vaccine(s)/product (Day −29 to Day 1), or planned use during the study period.
11. Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable (according to the participant’s age).
12. Previous vaccination with 2 or more doses of MenACWY vaccine.
13. Administration/planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before any dose of study vaccine(s)/product until the following post-vaccination blood sample.
14. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to any vaccine/product dose until the following post-vaccination blood sample. For corticosteroids (oral/intravenous/intramuscular), with mean prednisone ≥20 mg/day (for adult participants), or ≥0.5 mg/kg/day, or ≥20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
15. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product (drug or medical device).
16. Child in care.
17. Pregnant or lactating female.
18. Female planning to become pregnant or planning to discontinue contraceptive precautions (see inclusion criterion #8 for the necessary duration of contraception practice).
19. History of/current chronic alcohol and/or drug abuse.
20. Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity:
1. Percentages of participants with a 4-fold rise in human serum bactericidal assay (hSBA) titers against N. meningitidis serogroups A, C, W, and Y at 1 month after the first MenABCWY vaccine and after the single MenACWY vaccine
Safety:
2,3. Percentages of participants with solicited administration site events
2,3. Percentages of participants with solicited systemic events
4. Percentages of participants with any unsolicited adverse events (AEs) (including all serious adverse events [SAEs], AEs leading to withdrawal, AEs of special interest [AESIs] and medically attended AEs)
5. Percentages of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity
1. At 1 month after the first vaccination (i.e., Day 31)
Safety
2. During the 7 days (including day of vaccination) following vaccination at Day 1 for ABCWY group and ACWY group
3. During the 7 days (including day of vaccination) following vaccination at Day 181 for the ABCWY group and ACWY
4. During the 30 days (including day of vaccination) following vaccination at Day 1 for ABCWY group and ACWY group
5. From Day 1 to Day 361 (throughout the study period) |
|
| E.5.2 | Secondary end point(s) |
1. Percentages of participants with a 4-fold rise in hSBA titers against N. meningitidis serogroups A, C, W, and Y at 1 month after the second MenABCWY vaccine and after the single MenACWY vaccine
2. Percentages of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at day 1, 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine
3. hSBA Geometric mean titers (GMTs) against serogroups A, C, W, and Y at day 1, 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine
4. Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after first and second MenABCWY vaccine and after the single MenACWY vaccine
5. Percentages of participants with 4 fold rise in hSBA titers against each N. meningitidis serogroup B indicator strains at 1 month after second MenABCWY vaccine
6. GMTs against each serogroup B indicator strains at day 1, 1 month after second MenABCWY vaccine
7. GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccine |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity
1. At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group)
2. At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose])
3. At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose])
4. At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose]) versus Day 1
5. At Day 211
6. At Day 1 and Day 211
7. At Day 211 versus Day 1 |
|
| 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 | No |
| 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) | 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 | No |
| 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 | Yes |
| E.8.1.7.1 | Other trial design description |
|
| 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 | 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 |
| Argentina |
| Australia |
| Canada |
| United States |
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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
|
End of study (EoS): LSLV (Day 361) or last testing results released for the samples collected at Visit 4 (Day 211)*.
*Note: In this case, EoS must be achieved no later than 8 months after LSLV.
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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 years | 1 |
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