Status:
COMPLETED
ProQuad® Intramuscular vs Subcutaneous
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Measles
Mumps
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
Primary objective: To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age i...
Eligibility Criteria
Inclusion
- Healthy participant of either gender,
- Age 12 to 18 months,
- Negative clinical history of measles, mumps, rubella, varicella and zoster,
- Consent form signed by both holders of the parental authority or by the legal representative
- Holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion
- Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
- Any recent (≤30 days) exposure to measles, mumps, rubella, varicella and/or zoster
- Any recent (≤3 days) history of febrile illness
- Any severe chronic disease,
- Active untreated tuberculosis,
- Known personal history of seizure disorder,
- Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and 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 immunity including those resulting from corticosteroid \[any long-term (≥14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (≥2 mg/kg/day prednisone equivalent or ≥20 mg/day if weight more than 10 kg) within the previous 30 days\] or other immunosuppressive therapy,
- Any previous (≤ 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through Visit 3,
- Any recent (≤7 days) tuberculin test or scheduled tuberculin test through Visit 3,
- Any recent (≤30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through Visit 3,
Key Trial Info
Start Date :
October 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2007
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00402831
Start Date
October 6 2006
End Date
May 11 2007
Last Update
August 13 2018
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