Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella
Intervention: ProQuad® manufactured with recombinant Human Albumin (rHA)
Intervention description: A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1620.0
Sex: All
Minimum age: 9 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary study objectives are:

        -  To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human
           Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age
           at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at
           the time of Dose 1.

        -  To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval
           to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in
           healthy children of 12 months of age at the time of Dose 1.

        -  To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval
           to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is
           well-tolerated compared to children of 12 months of age at the time of Dose 1.

      The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a
      3-month interval to children of 11 months of age, would be non-inferior in terms of antibody
      response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the
      same regimen in children of 12 months of age at the time of Dose 1.

      If the first primary hypothesis was demonstrated, the second primary hypothesis was that a
      2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of
      age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella,
      and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age
      at the time of Dose 1.

      The secondary study objectives are:

        -  To describe the antibody titres to measles, mumps, rubella and varicella at Day 42
           following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9
           months of age.

        -  To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to
           healthy children from 9 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy subject of either gender of 9 months of age

          2. Negative clinical history of measles, mumps, rubella, varicella or zoster

          3. Informed consent form signed by both parents or legal representative

          4. Parent(s) or legal representative able to attend all the scheduled visits with the
             subject and to understand and comply with the study procedures

          5. Both parent or legal representative are over 18 years of age

          6. Subject is affiliated to a health social security system

        Exclusion Criteria:

          1. Febrile illness in the previous 3 days

          2. Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone
             or in any combination

          3. Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days

          4. Tuberculin test done in the previous 2 days

          5. Severe chronic disease

          6. Known active tuberculosis

          7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or
             unstable neurological condition

          8. Hereditary problems of fructose intolerance

          9. Prior known sensitivity or allergy to any component of the vaccine

         10. Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
             affecting the bone marrow or lymphatic systems

         11. Humoral or cellular immunodeficiency,

         12. Immunosuppressive therapy [including systemic corticosteroids (a), given daily or on
             alternate days at high doses (>=2 mg/kg/day prednisone equivalent or >=20 mg/day if
             the subject's weight was >10 kg) during at least 14 days in the previous 30 days]

         13. Family history of congenital or hereditary immunodeficiency

         14. Receipt of immunoglobulins or blood-derived products in the previous 150 days or
             scheduled to be administered through Visit 5

         15. Receipt of an inactivated vaccine in the previous 14 days

         16. Receipt of a live non-study vaccine in the previous 28 days

         17. Any medical condition which, in the opinion of the investigator, might have interfered
             with the evaluation of the study objectives

         18. Current participation or scheduled participation in any other clinical study through
             Visit 5