| 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) |
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| E.1.1.1 | Medical condition in easily understood language |
| Invasive meningococcal disease (IMD) |
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| 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 | 18.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10058858 |
| E.1.2 | Term | Meningococcal bacteraemia |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| 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 |
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| 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 |
E.2.1 Observational objectives:
•To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA)
•To evaluate the antibody responses against tetanus in subjects who received MenACYW conjugate vaccine or NIMENRIX vaccine
•To evaluate the safety profile of MenACYW conjugate vaccine and NIMENRIX®
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 12 to 23 months on the day of the first study visit
2) Born at full term of pregnancy (≥ 37 weeks) or with a birth weight ≥ 2.5 kg (5.5 pounds)
3) Informed consent form (ICF) has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
5) Covered by health insurance where applicable
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| E.4 | Principal exclusion criteria |
An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which may be received at least 2 weeks before or after the study vaccines
3) Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y
4) Receipt of immune globulins, blood, or blood-derived products in the past 3 months
5) 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 (≥ 2mg/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
6) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
7) At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
8) Known systemic hypersensitivity to any of the vaccine components, history of a life-threatening reaction to the vaccines used in the trial, or to a vaccine containing any of the same substances
9) Known systemic hypersensitivity to latex
10) Known thrombocytopenia, as reported by the parent/legally acceptable representative
11) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
12) Personal history of Guillain-Barré syndrome (GBS)
13) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
15) 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.
16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity
The following serological endpoints will be assessed immediately before and 30 days after vaccination:
• Antibody titers against meningococcal serogroups A, C, Y, and W measured by rSBA and hSBA for Group 1 and Group 2.
• Tetanus toxoid is contained in both the investigational and control vaccines as a carrier protein. Therefore, blood samples will also be tested for anti-tetanus antibodies by enzyme-linked immunosorbent assay (ELISA). The following parameters will be assessed:
• At both pre- and post-vaccination time point, geometric mean concentrations (GMCs)
• At both pre- and post-vaccination time points, the proportion of subjects achieving seroprotective levels ≥ 0.01 IU/milliliters (mL) and ≥ 0.1 IU/mL of antibody concentrations to tetanus toxoid
Safety
• Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, intensity, and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after vaccination.
• Occurrence, time to onset, number of days of occurrence, intensity, action taken, and whether the reaction led to early termination from the study, of solicited (prelisted in the subject’s diary card and electronic Case Report form [CRF]) injection site reactions occurring up to 7 days after vaccination.
• Occurrence, time to onset, number of days of occurrence, intensity, action taken, and whether the reaction led to early termination from the study, of solicited (prelisted in the subject’s diary card and CRF) systemic reactions occurring up to 7 days after vaccination.
• Occurrence, nature (MedDRA preferred term), time to onset, duration, intensity, action taken, relationship to vaccination (for systemic AEs only), and whether the event led to early termination from the study, of unsolicited AEs up to 30 days after vaccination.
• Occurrence, nature (MedDRA preferred term), time to onset, duration, seriousness criteria, relationship to vaccination, outcome, and whether the serious adverse event (SAE) led to early termination from the study of SAEs throughout the trial.
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 30-44 days after the vaccination |
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| E.5.2 | Secondary end point(s) |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | No |
| 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 | 2 |
| 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 | 6 |
| 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
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| 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 | |
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