Status:
COMPLETED
Safety Study of a Refrigerator-stable Formulation of VARIVAX®
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Varicella
Measles
Eligibility:
All Genders
12-15 years
Phase:
PHASE4
Brief Summary
Primary objective: To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-v...
Eligibility Criteria
Inclusion
- Healthy infants from 12 months of age to 15 months of age.
- Consent form signed by both parents or by the legal representative(s), properly informed about the study,
- Parent(s) 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 known recent (≤30 days) exposure to measles, mumps or rubella,
- Any known recent (≤30 days) exposure to varicella or zoster involving:
- Any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°C),
- Active untreated tuberculosis,
- Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
- Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
- Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 3,
- Any recent receipt of an inactivated or a live vaccine (≤ 30 days) or scheduled vaccination through visit 3
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00432731
Start Date
December 1 2004
End Date
September 1 2005
Last Update
March 14 2017
Active Locations (25)
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1
Amboise, France
2
Ancenis, France
3
Betton, France
4
Châteaubriant, France