Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)
- Conditions
- MumpsMeaslesVaricella
- Registration Number
- NCT00432523
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.
AND/OR
To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination
Secondary objectives:
* To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
* To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method