E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against Measels, Mumps, Rubella and Varicella |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021430 |
E.1.2 | Term | Immunisation |
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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 |
To describe the safety profile of a second dose of ProQuad manufactured with rHA when administered to children in their second year of life |
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E.2.2 | Secondary objectives of the trial |
To describe the safety profile of a first dose of ProQuad manufactured with rHA when administered to children in their second year of life |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy subject of either gender 2. Age from 12 to 22 months (from the 12 month birthday to one day prior to the 23rd month birthday), 3. Negative clinical history of infection with measles, mumps, rubella, varicella or zoster, 4. Informed consent form signed by the parent(s) or by legal representative according to the local regulations 5. Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures (i.e. able to read and write). |
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E.4 | Principal exclusion criteria |
1. Recent (≤ 3 days) history of febrile illness (defined as rectal temperature ≥ 38.0C) 2. Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination 3. Recent ( 30 days) exposure to measles, mumps, rubella, varicella or zoster involving: continuous household contact, or, playmate contact (generally >1 hour of play indoors), or hospital contact (in same 2- to 4-bed room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject), or contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery, 4. Prior known sensitivity/allergy to any component of the vaccine including neomycin, sorbitol or gelatin, or true allergy to egg proteins (anaphylactic or anaphylactoid reaction after ingesting eggs) 5. Severe chronic disease, 6. Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system 7. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection 8. Humoral or cellular (primary or acquired) immunodeficiency, including hypogammaglobulinemia and dysgammaglobulinemia and AIDS, or symptomatic HIV infection 9. Current immunosuppressive therapy (including systemic corticosteroids given daily or on alternate days at 20 mg/day prednisone equivalent during 14 days within the past 30 days) 10. Family history of congenital or hereditary immunodeficiency 11. Hereditary problems of fructose intolerance 12. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition, 13. Known active tuberculosis 14. Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3 15. Receipt of immunoglobulins or blood-derived products in the past 150 days 16. Receipt of an inactivated vaccine in the past 14 days 17. Receipt of a live vaccine in the past 28 days 18. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 19. Participation to another clinical study in the past 30 days |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Evaluation criteria: The primary safety criteria will describe the safety profile of a second dose of ProQuad manufactured with rHA when administered to children in their second year of life. |
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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 | 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 | No |
E.8.1.2 | Open | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
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
|
ultima visita ultimo soggetto |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |