EUCTR2007-002438-12-DKActive, not recruitingPhase 1
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
Sanofi Pasteur MSD S.N.C.0 sites3,388 target enrollmentStarted: August 9, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,388
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subject will be included in the study if he / she meets all the following 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
- •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
- •If any of the following criteria are met, subject must not be included in the study:
- •1. Recent (= 3 days) history of febrile illness (defined as rectal temperature = 38.0°C)
- •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
- •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
- •There are also a list of temporary contra-indications and a list of definite contra-indications to the further vaccination. See study protocol page 20 for the detailed lists.
Investigators
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