A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
NCT ID: NCT00231816
Last Updated: 2015-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
763 participants
INTERVENTIONAL
2005-09-30
2006-03-31
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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Concomitant
Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4
ZOSTAVAX™ (concomitant)
a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4
Comparator: Influenza Vaccine
a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
Nonconcomitant
Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4
Comparator: Influenza Vaccine
a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
ZOSTAVAX™ (Nonconcomitant)
Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4
Interventions
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ZOSTAVAX™ (concomitant)
a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4
Comparator: Influenza Vaccine
a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
ZOSTAVAX™ (Nonconcomitant)
Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4
Other Intervention Names
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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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Kerzner B, Murray AV, Cheng E, Ifle R, Harvey PR, Tomlinson M, Barben JL, Rarrick K, Stek JE, Chung MO, Schodel FP, Wang WW, Xu J, Chan IS, Silber JL, Schlienger K. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc. 2007 Oct;55(10):1499-507. doi: 10.1111/j.1532-5415.2007.01397.x.
Sutradhar SC, Wang WW, Schlienger K, Stek JE, Xu J, Chan IS, Silber JL. Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. Clin Vaccine Immunol. 2009 May;16(5):646-52. doi: 10.1128/CVI.00407-08. Epub 2009 Mar 4.
Other Identifiers
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2005_036
Identifier Type: -
Identifier Source: secondary_id
V211-011
Identifier Type: -
Identifier Source: org_study_id
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