E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary immunization of healthy subjects aged 1 through 10 years against meningococcal disease due to serogroup A, C, W-135 or Y. |
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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: For Subjects of two years of age and above • To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed Mencevax ACWY in terms of the vaccine response to MenA, MenC, MenY and MenW-135* *Response to a vaccine antigen component is defined as : - for initially seronegative subject, post vaccination rSBA titer ≥ 1:32 - for initially seropositive subject, at least 4-fold increase in rSBA titre from pre to post vaccination For Subjects below two years of age • To evaluate the non-inferiority of the vaccine response induced by the MenACWY-TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroup C as measured by serum bactericidal antibodies (rSBA). • To evaluate the immunogenicity induced by the MenACWY-TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroups A, W-135, and Y as measured by rSBA.
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E.2.2 | Secondary objectives of the trial |
1m post vacc: 1) to compare the immunogenicity of MenACWY-TT with that of Mencevax ACWY (subjects≥ 2y)/Meningitec (subjects < 2y). 2) To evaluate the reactogenicity of MenACWY-TT when compared to Mencevax ACWY (subjects≥ 2y)/Meningitec (subjects < 2y). To assess the safety profile of MenACWY-TT when compared to Mencevax ACWY (subjects≥ 2y)/Meningitec (subjects < 2y) in terms of any grade 3 systemic symptom 0-3d post vacc. To describe SAEs, specific AEs, and conditions prompting emergency room/ physician office visits that are not related to well-being care, vaccination, injury, or common acute illnesses and any event related to lack of vaccine efficacy up to 6 m after vaccination. 1-5 y post vaccination: to compare the persistence of the immunogenicity of MenACWY-TT with that of Mencevax ACWY (subjects≥ 2y)/Meningitec (subjects < 2y). To describe SAEs related to vaccination and any event related to lack of vaccine efficacy from 6 m up to 5y post vacc in a retrospective manner.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects must satisfy the following criteria at study entry: • Subjects who the investigator believes that their parent or legally acceptable representative 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, 1 through 10 years of age at the time of vaccination. • Written informed consent obtained from the parent or legally acceptable representative 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/legally acceptable representative’s knowledge (however, previous meningococcal vaccination is an exclusion criterion)
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E.4 | Principal exclusion criteria |
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, 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 mean prednisone ≥0.5 mg/kg/day or its equivalent. Inhaled and topical steroids are allowed.) • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above). • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y. • previous vaccination with tetanus toxoid containing vaccine within the last 28 days. • History of meningococcal disease due to serogroup A, C, W or Y • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. • A family history of congenital or hereditary immunodeficiency. • 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. • 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., Oral temperature <37.5°C / Rectal temperature <38°C / Tympanic temperature on oral setting <37.5°C / Axillary temperature <37.5°C) • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Specific criteria to be checked at each study visit for the long term follow-up:
• History of meningococcal serogroup A,C, W and Y disease. • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol
In case one of the two exclusion criteria above becomes applicable during the long-term follow-up, the subject will not enter the long-term follow-up of that particular year and the years that follow and the reason will be documented.
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E.5 End points |
E.5.1 | Primary end point(s) |
For Subjects of two years and above, one month post vaccination: • Vaccine response to MenA, MenC, MenY and MenW-135 defined as: - for initially seronegative subject, post vaccination rSBA titer ≥ 1:32 - for initially seropositive subject, at least 4-fold increase in rSBA titre from pre to post vaccination For Subjects below two years of age, prior to and one month after vaccination • group MenACWY-TT: rSBA-MenA, rSBA-MenC, rSBA-MenW and rSBA-MenY titres ≥1:8 • group control Meningitec: rSBA-MenC titres ≥1:8
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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 | 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 |
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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.8.3 |
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 | 11 |
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 | 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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Last subject last visit (Month 60) |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |