An open, randomised, comparative, multicentre study of the immunogenicity and safety of M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® when administered concomitantly by intramuscular (IM) route or subcutaneous (SC) route at two separate injection sites in healthy subjects 12 to 18 months of age - MMR rHA + VARIVAX IM or SC in 12-18 month-old healthy subjects

• Conditions: ot applicable - Healthy subjects

• Registration Number: EUCTR2004-002586-21-DE
• Lead Sponsor: Aventis Pasteur MSD SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified