Safety Study of a Refrigerator-stable Formulation of VARIVAX®
Phase 4
Completed
- Conditions
- RubellaVaricellaMumpsMeasles
- Registration Number
- NCT00432731
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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-vaccination.
Secondary objectives: NA
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does refrigerator-stable VARIVAX®'s VZV glycoprotein expression compare to standard formulations in 12-15 month-old infants?
What are the comparative safety and immune response profiles of refrigerator-stable versus standard VARIVAX® in pediatric populations?
Which cytokine or immune biomarkers predict adverse events in refrigerator-stable VARIVAX®-vaccinated infants during 42-day follow-up?
What adverse events are associated with refrigerator-stable VARIVAX® in early childhood and how are they managed clinically?
How does Merck's refrigerator-stable VARIVAX® compare to competitor varicella vaccines in terms of stability and safety in Phase 4 trials?