| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Invasive meningococcal disease (IMD) |
|
| 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 | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10027274 |
| E.1.2 | Term | Meningococcal infection |
| 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 non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority is demonstrated, then
- the non-inferiority of the antibody response (geometric mean titers [GMT]). If this non-inferiority is demonstrated, then
- the superiority of the antibody response (GMT). If this superiority is demonstrated, then
- the superiority of the seroprotection rate
Or to demonstrate :
- the non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate or NeisVac-C® as measured by rSBA. If this non-inferiority is demonstrated, then
- the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
- the superiority of the antibody response (GMT) |
|
| E.2.2 | Secondary objectives of the trial |
To demonstrate the following:
- the non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate vaccine or Nimenrix® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority is demonstrated, then
- the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
- the superiority of the antibody response (GMT).
Or to demonstrate the following:
- the non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority is demonstrated, then
- the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
- the superiority of the antibody response (GMT) .
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Aged 12 to 23 months on the day of the first study visit (“12 to 23 months” means from the 12th month after birth to the day before the 24th month after birth)
- Informed consent form (ICF) has been signed and dated by the parent(s) / legally acceptable representative(s) and by an independent witness if required by local regulations.
- Subject and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
|
|
| E.4 | Principal exclusion criteria |
- Participation in the 4 weeks (28 days) preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B vaccine).
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances .
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
- Personal history of Guillain-Barré syndrome (GBS).
- Thrombocytopenia, as reported by the parent/ legally acceptable representative or suspected thrombocytopenia contraindicating intramuscular vaccination in the Investigator’s opinion.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator’s opinion.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Antibody titers against meningococcal serogroup C ≥ 1:8 after vaccination with MenACYW conjugate vaccine or Nimenrix® (hSBA assessment) : Percentage of participants achieving seroprotection, defined as antibody titers equal or greater than (≥) 1:8 as measured by serum bactericidal assay using human complement (hSBA)
Antibody titers against meningococcal serogroup C after vaccination with MenACYW conjugate vaccine or Nimenrix® (hSBA assessment) : Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroup C as measured by hSBA
Antibody titers against meningococcal serogroup C ≥ 1:8 after vaccination with MenACYW conjugate vaccine or NeisVac-C® (rSBA assessment) : Percentage of participants achieving seroprotection, defined as antibody titers ≥ 1:8 as measured by serum bactericidal assay using baby rabbit complement (rSBA) Antibody titers against meningococcal serogroup C after vaccination with MenACYW conjugate vaccine or NeisVac-C® : GMTs of antibodies against meningococcal serogroup C as measured by rSBA
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
-Antibody titers against meningococcal serogroup C ≥ 1:8 : Percentage of participants achieving seroprotection (antibody titers ≥ 1:8) as measured by rSBA after vaccination with MenACYW conjugate vaccine or Nimenrix®
- Antibody titers against meningococcal serogroup C : GMTs of antibodies against meningococcal serogroup C as measured by rSBA after vaccination with MenACYW conjugate vaccine or Nimenrix®
- Antibody titers against meningococcal serogroup C ≥ 1:8 : Percentage of participants achieving seroprotection (antibody titers ≥ 1:8) as measured by hSBA after vaccination with MenACYW conjugate vaccine or NeisVac-C®
- Antibody titers against meningococcal serogroup C : GMTs of antibodies against meningococcal serogroup C as measured by hSBA after vaccination with MenACYW conjugate vaccine or NeisVac-C® |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | Yes |
| 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 | 3 |
| 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 | 10 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 31 |
| 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
|
|
| 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 | |
| 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 | 1 |
Print
