Not applicable - Healthy subjects
Conditions
Interventions
Trade Name: VARIVAX
Product Name: VARIVAX
Product Code: V210
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Varicella live vaccine
Current Sponsor code: V210
Sponsors
Aventis Pasteur MSD SNC
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ( 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 = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;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 rub | — |
Countries
Germany
Outcome results
None listed