Combined Measles, Mumps, Rubella and Varicella Live Vaccine MedDRA version: 9.1 Level: LLT Classification code 10000639 Term: Active immunisation MedDRA version: 9.1 Level: LLT Classification code 10039242 Term: Routine childhood immunisation MedDRA version: 9.1 Level: LLT Classification code 10036897 Term: Prophylactic vaccination
Conditions
Interventions
Product Name: ProQuad® (manufactured with rHA)
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: Measles virus Enders’ Edmonston strain (live attenuated)
Con
Sponsors
Sanofi Pasteur MSD S.N.C.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany, Greece, Italy, Netherlands, Spain, Sweden
Outcome results
None listed