| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Single dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy subjects aged 2 through 10 years. |
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| 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 |
One month after vaccination:
•To demonstrate non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed conjugate vaccine (MenC-CRM197) in terms of serum bactericidal antibody vaccine response to N. meningitidis serogroup C.
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| E.2.2 | Secondary objectives of the trial |
Immunogenicity
One month after vaccination:
In subjects of the MenACWY-TT group:
•To evaluate the immunogenicity of MenACWY-TT conjugate vaccine for N. meningitidis serogroup A, W-135 and Y.
In subjects of the MenACWY-TT and MenCCRM groups:
•To compare the immunogenicity of MenACWY-TT conjugate vaccine to the licensed conjugate vaccine (MenC-CRM197) in terms of serogroup C serum bactericidal antibodies (rSBA-MenC) and anti-PSC antibodies.
Safety
One month after vaccination, in all subjects:
•To evaluate the safety and reactogenicity of one dose of MenACWY-TT conjugate vaccine and of MenC-CRM197 vaccine.
Up to six months after vaccination (Month 6), in all subjects:
•To describe serious adverse events (SAEs).
•To describe specific adverse events (AEs) of rash, new onset chronic illness(es), and conditions prompting emergency room (ER) visits.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A male or female between, and including, 2 and 10 years of age at the time of the vaccination.
•Written informed consent obtained from the parent(s) or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Previously completed routine childhood vaccinations to the best of his/her parents’/guardians’ knowledge.
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| E.4 | Principal exclusion criteria |
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will be prednisone at >= 0.5 mg/kg/day or equivalent. Inhaled and topical steroids are allowed).
•Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after.
•Concurrently participating in another clinical study or planned participation 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 product (pharmaceutical product or device).
•Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W-135 and/or Y (for subjects below 6 years) or within the last five years (for subjects 6 years old and above).
•Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y.
•History of meningococcal disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
•A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Major congenital defects or serious chronic illness.
•History of any neurologic disorders or seizures (although subjects with a prior history of 2 or less episodes of benign febrile seizures may be allowed to participate in the study).
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Rectal temperature <38°C / Oral temperature <37.5°C / Axillary temperature <37.5°C / Tympanic temperature on oral setting <37.5°C.
•Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccine dose or planned administration during the study period. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
One month after vaccination in all subjects:
•Vaccine response to MenC.
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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) | 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 | 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.8.3 |
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 | 26 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 36 |
| 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 | Information not present in EudraCT |
| 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 | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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