An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of a 2-dose regimen of ProQuad® manufactured with rHA administered to healthy children from 9 months of age
- Conditions
- Measles, mumps, rubella and varicella vaccine administered to healthy children from 9 months of age
- Registration Number
- EUCTR2007-002468-88-DE
- Lead Sponsor
- Sanofi Pasteur MSD SNC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1620
1. Healthy subject of either gender
2. Subject 9 months of age [from the 9th month birthday to 1 day prior to the 10th month birthday, preferably the 2 first weeks after the 9th month birthday]
3. Negative clinical history of measles, mumps, rubella, varicella or zoster
4. Informed consent form signed by both parents or legal representative according to the local regulations
5. Parent(s) or legal representative able to attend all scheduled visits with the subject and to understand and comply with the study procedures (i.e. able to read and write)
6. Both parent(s) or legal representative over 18 years of age
7. Subject affiliated to a health social security system.
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
1. Febrile illness in the previous 3 days (rectal temperature ³38.0°C) (a)
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(a)
4. Tuberculin test done in the previous 2 days (a)
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 vaccines including neomycin, sorbitol or gelatin, or true allergy to egg proteins (anaphylactic or anaphylactoid reaction after ingesting eggs)
10. Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
11. Humoral or cellular (primary or acquired) immunodeficiency, including hypogammaglobulinemia and dysgammaglobulinemia and AIDS, or symptomatic HIV infection
12. Immunosuppressive therapy [including systemic corticosteroids(a), given daily or on alternate days at high doses (³2 mg/kg/day prednisone equivalent or ³20 mg/day if the subject's weight is >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 within the previous 14 days (a)
16. Receipt of a live non-study vaccine within the previous 28 days (a)
17. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
18. Current participation or scheduled participation in any other clinical study through Visit 5 (a).
(a) Should a subject meet at least one of those criteria at Visit 1, inclusion will be postponed until this criteria is not met anymore, within the targeted age window. If the condition is not resolved within the targeted window, the subject should not be included.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method