Status:
COMPLETED
Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Measles
Mumps
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
Primary objective: To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route i...
Eligibility Criteria
Inclusion
- Healthy subject of either gender,
- Age 12 to 18 months ,
- Consent form signed by both parent(s) or by the legal representative properly informed about the study,
- Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion
- Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
- Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
- Any recent (≤30 days) exposure to measles, mumps or rubella,
- Any recent (≤30 days) exposure to varicella or zoster involving:
- Any recent (≤3 days) history of febrile illness
- Any severe chronic disease,
- Active untreated tuberculosis,
- Known personal history of seizures,
- Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
- Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
- Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
- Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2
Key Trial Info
Start Date :
January 20 2005
Trial Type :
INTERVENTIONAL
End Date :
September 5 2005
Estimated Enrollment :
752 Patients enrolled
Trial Details
Trial ID
NCT00432523
Start Date
January 20 2005
End Date
September 5 2005
Last Update
October 18 2021
Active Locations (2)
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1
France, France
2
Germany, Germany