E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active immunization of healthy children during their second year of life against measles, mumps, rubella, varicella and Neisseria meningitidis C diseases |
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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 |
To demonstrate the non-inferiority in terms of immunogenicity of the first dose of MMRV vaccine co administered with MenC 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. To demonstrate the non-inferiority of MenC conjugate vaccine co administered with MMRV compared to MenC conjugate vaccine alone in terms of serum bactericidal antibodies against Neisseria meningitidis serogroup C |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and reactogenicity of the study vaccines |
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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 child between, and including, 12 and 23 months of age (including the day before the 24-month birthday) at the time of vaccination. Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure. 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 six weeks 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 first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) Planned administration/ administration of a vaccine not foreseen by the study protocol within six weeks prior until six weeks after the study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time; routine inactivated vaccines, except those containing diphtheria or tetanus toxoid, can be administered up to two weeks before the study vaccine dose. Previous vaccination against measles, mumps, rubella, varicella and/or Neisseria meningitidis serogroup C. History of measles, mumps, rubella, varicella and/or Neisseria meningitidis serogroup C diseases. Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the study start. Any confirmed or suspect 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. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to 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 fever, i.e., Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F). Axillary temperature greater than or equal to 37.5°C (99.5°F) / Rectal temperature greater than or equal to 38.0°C (100.4°F). Residence in the same household as a high risk person e.g. newborn infant (0-4 weeks of age), pregnant women who have a negative history for chickenpox, persons with known immunodeficiency.
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E.5 End points |
E.5.1 | Primary end point(s) |
43 days after the first vaccine dose (Post vacc I, study Day 43): Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella rSBA-MenC titres greater than or equal to 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
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 | 25 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |