A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
NCT ID: NCT00130793
Last Updated: 2015-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
368 participants
INTERVENTIONAL
2005-08-31
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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zoster vaccine live (Oka/Merck) refrigerated formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection
Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
zoster vaccine live (Oka/Merck) frozen formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection
Comparator: zoster vaccine live (Oka/Merck) frozen formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
Interventions
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Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
Comparator: zoster vaccine live (Oka/Merck) frozen formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior receipt of varicella or zoster vaccine
* Immunosuppressed
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Gilderman LI, Lawless JF, Nolen TM, Sterling T, Rutledge RZ, Fernsler DA, Azrolan N, Sutradhar SC, Wang WW, Chan IS, Schlienger K, Schodel F, Silber JL; Zostavax Protocol 010 Study Group. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax. Clin Vaccine Immunol. 2008 Feb;15(2):314-9. doi: 10.1128/CVI.00310-07. Epub 2007 Dec 12.
Other Identifiers
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2005_035
Identifier Type: -
Identifier Source: secondary_id
V211-010
Identifier Type: -
Identifier Source: org_study_id
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