Status:
COMPLETED
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Varicella
Eligibility:
All Genders
12-23 years
Phase:
PHASE3
Brief Summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 201...
Eligibility Criteria
Inclusion
- Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella
Exclusion
- Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
- Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
- Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
- History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX® or M-M-R II®
- Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
- Received salicylates within 14 days prior to study vaccination
- Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
- Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
- History of seizure disorder, including febrile seizure
- Fever illness (\>=102.2 °F \[39.0 °C\] within 72 hours prior to study vaccination
- History of thrombocytopenia
- Born to a human immunodeficiency virus (HIV)-infected mother
- Has a diagnosis of active untreated tuberculosis
- Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03239873
Start Date
October 17 2017
End Date
April 2 2019
Last Update
January 27 2021
Active Locations (37)
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1
Alabama Clinical Therapeutics ( Site 0018)
Birmingham, Alabama, United States, 35205
2
Children's Clinic of Jonesboro, PA ( Site 0030)
Jonesboro, Arkansas, United States, 72401
3
Southland Clinical Research Center ( Site 0017)
Anaheim, California, United States, 92804
4
Premier Health Research Center, LLC ( Site 0044)
Downey, California, United States, 90240