Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
NCT ID: NCT02519855
Last Updated: 2018-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
882 participants
INTERVENTIONAL
2015-09-11
2016-01-26
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 Vaccination
ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
Placebo to ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)
Influenza Vaccine
A single open-label administration of 0.5 mL intramuscular injection on Day 1
Nonconcomitant Vaccination
Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
Placebo to ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)
Influenza Vaccine
A single open-label administration of 0.5 mL intramuscular injection on Day 1
Interventions
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ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
Placebo to ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)
Influenza Vaccine
A single open-label administration of 0.5 mL intramuscular injection on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study
Exclusion Criteria
* Has previously received any varicella or zoster vaccine
* Has received an influenza vaccine for the 2015-16 season
* Has history of Herpes zoster
* Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
* Is pregnant or breastfeeding, or expecting to conceive during the study
* Has used immunosuppressant therapy
* Has known or suspected immune dysfunction
* Has experienced Guillain-Barré syndrome within 6 weeks
* Has severe thrombocytopenia or any other coagulation disorder
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 Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Levin MJ, Buchwald UK, Gardner J, Martin J, Stek JE, Brown E, Popmihajlov Z. Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine. Vaccine. 2018 Jan 2;36(1):179-185. doi: 10.1016/j.vaccine.2017.08.029. Epub 2017 Aug 19.
Other Identifiers
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V211-062
Identifier Type: -
Identifier Source: org_study_id
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