| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| One dose primary immunization against Neisseria meningitidis serogroups A, C, W-135, and Y when given alone or when co-administered with a first dose of Priorix-Tetra in healthy children aged 12 to 23 months. |
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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 |
42 days after the first vaccine dose
•To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to Meningitec, the licensed conjugate vaccine for N. meningitidis serogroup C, in terms of serogroup C serum bactericidal antibodies (rSBA-MenC).
•To demonstrate the immunogenicity induced by the MenACWY-TT conjugate vaccine for N. meningitidis serogroups A, W-135, and Y in terms of bactericidal antibodies to N. meningitidis serogroups A, W-135, and Y.
•To demonstrate the non-inferiority of MenACWY-TT conjugate vaccine co-administered with MMRV compared to MenACWY-TT conjugate vaccine alone in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135, and Y.
•To demonstrate the non-inferiority of the immunogenicity of the first dose of MMRV vaccine co-administered with MenACWY-TT conjugate vaccine compared to the first dose of MMRV vaccine alone with respect to anti-measles, anti-mumps, anti-rubella, and anti-varicella seroconversion rates.
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| E.2.2 | Secondary objectives of the trial |
To compare the immunogenicity of the MenACWY-TT vaccine to that of Meningitec vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C
To compare the immunogenicity of the MenACWY-TT vaccine co-administered with MMRV vaccine to that of Meningitec vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C
To compare the immunogenicity of the MenACWY-TT vaccine co-administered with MMRV vaccine to that of the MenACWY-TT vaccine alone in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135 and Y
To evaluate the immunogenicity of the second dose of MMRV vaccine
To evaluate the safety profile of MenACWY-TT, MenACWY-TT co-administered with MMRV vaccine, MMRV vaccine and Meningitec
To describe serious adverse events and specific adverse events of rash, new onset chronic illness(es), and ER/non-routine physician office visits occurring up to 6 months after the first vaccination
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Subjects who the investigator believes that their parents/guardians 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, 12 and 23 months of age at the time of the vaccination.
•Written informed consent obtained from the parent 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 parents’ or legal 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 vaccine(s) within 30 days preceding the first 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 >= 0.5 mg/kg/day prednisone or equivalent. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the dose of vaccine(s).
•Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
•History of meningococcal disease
•Previous vaccination against measles, mumps, rubella, and/or varicella.
•History of measles, mumps, rubella or varicella.
•Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
•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).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
•Major congenital defects or serious chronic illness.
•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 (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F) / Tympanic temperature on oral setting <37.5°C (99.5°F)
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. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
•rSBA-MenC titres, rSBA-MenA, rSBA-MenW-135 and rSBA-MenY titres >=1:8
•Anti-measles concentrations >=150 mIU/ml (seropositivity)
•Anti-mumps concentrations >=231 U/ml (seropositivity)
•Anti-rubella concentrations >=4 IU/ml (seropositivity)
•Anti-varicella titres >= 4-fold dilution-1 (seropositivity)
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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) | 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 | 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 visit, last subject (last visit can be handled by phone contact) |
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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 | 0 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
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