Safety Study of ProQuad® rHA in Infants (V221-037)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: ProQuad®
Intervention description: ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3388.0
Sex: All
Minimum age: 12 Months
Maximum age: 22 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention of: measles, mumps, rubella and varicella

Summary:

      Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured
      with recombinant human albumin (rHA) when administered to children in their second year of
      life.

      Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured
      with rHA when administered to children in their second year of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subject of either gender,

          -  Age from 12 to 22 months,

          -  Negative clinical history of infection with measles, mumps, rubella, varicella or
             zoster,

          -  Informed consent form signed by the parent(s) or by legal representative

          -  Parent(s) or legal representative able to attend all schedule visits with the subject
             and to understand and comply with the study procedures

        Exclusion Criteria:

          -  Recent (≤ 3 days) history of febrile illness

          -  Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or
             in any combination

          -  Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster

          -  Prior known sensitivity/allergy to any component of the vaccine

          -  Severe chronic disease,

          -  Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms
             affecting the haematopoietic and lymphatic system

          -  Any severe thrombocytopenia or any other coagulation disorder that would
             contraindicate intramuscular injection

          -  Humoral or cellular immunodeficiency,

          -  Current immunosuppressive therapy

          -  Family history of congenital or hereditary immunodeficiency

          -  Hereditary problems of fructose intolerance

          -  Known personal history of encephalopathy, seizure disorder or progressive, evolving or
             unstable neurological condition,

          -  Known active tuberculosis

          -  Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3

          -  Receipt of immunoglobulins or blood-derived products in the past 150 days

          -  Receipt of an inactivated vaccine in the past 14 days

          -  Receipt of a live vaccine in the past 28 days

          -  Any medical condition which, in the opinion of the investigator, might interfere with
             the evaluation of study objectives

          -  Participation in another clinical study in the past 30 days