Measles, mumps, rubella and varicella vaccine administered to healthy children from 9 months of age
Conditions
Interventions
Product Name: ProQuad® manufactured with rHA
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: Measles virus1 Enders’ Edmonston strain (live attenuated)
Con
Sponsors
Sanofi Pasteur MSD SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 met, within the targeted age window. If the condition is not resolved within the targeted window, the subject should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first primary objective is to demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy childrenof 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, in terms of antibody response rates to measles, mumps, rubella and varicella at Day 42 following Dose 2. The second primary objective, only if the first primary objective is reached, is similar to the first one at 9 months of age. 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 healthy children of 12 months of age at the time of Dose 1. ;Secondary Objective: 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. ;Primary end point(s): The primary immunogenicity endpoints will be the antibody response rates to measles, mumps, rubella and varicella measured at Day 42 following Dose 2 (Blood sample 3). - The response rate for measles is the percentage of subjects with measles antibody titres ³255 mIU/mL. - The response rate for mumps is the percentage of subjects with mumps antibody titres ³10.0 ELISA Ab units/mL. - The response rate for rubella is the percentage of subjects with rubella antibody titres ³10.0 IU/mL. - The response rate for varicella is the percentage of subjects with varicella antibody titres ³5 gpELISA units/mL. | — |
Countries
Finland, France, Germany
Outcome results
None listed