| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Not applicable - Healthy subjects |
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| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To demonstrate that, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-R™II manufactured with rHA administered by IM route is as immunogenic as a single dose of M-M-R™II manufactured with rHA administered by SC route in terms of response rates to measles, mumps and rubella as measured by ELISA at 42 days following the vaccination.
and/or
To demonstrate that, when given concomitantly with M-M-R™II manufactured with rHA by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella as measured by gpELISA at 42 days following the vaccination.
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| E.2.2 | Secondary objectives of the trial |
1)Immunogenicity
To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children 12 to 18 months of age immunised with M-M-R™II manufactured with rHA and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.
2) Safety
To evaluate the safety profiles of M-M-R™II manufactured with rHA and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
Subjects will be included in the study if they meet all of the following inclusion criteria:
1. Healthy subjects of either gender,
2. Age 12 to 18 months [from the 12th month birthday to 1 day prior to the 19th month birthday],
3. Consent form signed by both parent(s) or by the legal representative properly informed about the study,
4. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
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| E.4 | Principal exclusion criteria |
Subjects will not be included in the study if they meet any of the following non-inclusion criteria:
1. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
2. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
3. Any recent ( < or = 30 days) exposure to measles, mumps or rubella,
4. Any recent (< or = 30 days) exposure to 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,
5. Any recent (< or = 3 days) history of febrile illness (rectal temperature > or = 38.0°C),
6. Any severe chronic disease,
7. Active untreated tuberculosis,
8. Known personal history of seizures,
9. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
10. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (> or =14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses ( > or = 2mg/kg/day prednisone equivalent or > or = 20mg/day if weight more than 10kg) within the previous 30 days] or other immunosuppressive therapy
12. Any recent tuberculin test (< or = 7 days) or scheduled tuberculin test through visit 2,
13. Any previous (< or = 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
14. Any recent receipt of an inactivated or a live vaccine (< or = 30 days) or scheduled vaccination through visit 2,
15. Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin,
16. True allergy to egg proteins (anaphylatic or anaphylactoid reaction after ingesting eggs),
17. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives,
18. Subject that, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements,
19. Any recent participation (< or = 30 days) or scheduled participation in any other clinical trial through visit 2
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary immunogenicity criteria are the response rates to measles, mumps, rubella and varicella measured 42 days following the vaccination in both groups.
The response rate for measles is the percentage of subjects with measles antibody titres ³255 mIU/mL in subjects whose baseline measles antibody titre is <255 mIU/mL. The response rate for mumps is the percentage of subjects with mumps antibody titres ³10 ELISA antibody units/mL in subjects whose baseline mumps antibody titre is <10 ELISA antibody units/mL. The response rate for rubella is the percentage of subjects with rubella antibody titres ³10 IU/mL in subjects whose baseline rubella antibody titre is <10 IU/mL. The response rate for varicella is the percentage of subjects with varicella antibody titres ³5 gpELISA units/mL in subjects whose baseline varicella antibody titre is <1.25 gpELISA units/mL.
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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 | No |
| 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 | Information not present in EudraCT |
| 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) | 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.8.5 | 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 | Information not present in EudraCT |
| 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 of the last subject |
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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 | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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