An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad) Manufactured with Recombinant Human Albumin (rHA) when administered to Children in their Second Year of Life - ND

• Conditions: Immunization against Measels, Mumps, Rubella and Varicella; MedDRA version: 9.1Level: LLTClassification code 10021430Term: Immunisation

• Registration Number: EUCTR2007-002438-12-IT
• Lead Sponsor: CASA MADRE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3340

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).
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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the safety profile of a second dose of ProQuad manufactured with rHA when administered to children in their second year of life;Secondary Objective: To describe the safety profile of a first dose of ProQuad manufactured with rHA when administered to children in their second year of life;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.