A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)
NCT ID: NCT02180295
Last Updated: 2015-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2014-07-31
2015-03-31
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
TRIPLE
Study Groups
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V212 Lot 1
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
V212 Lot 1
Inactivated Varicella Zoster Virus vaccine
V212 Lot 2
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
V212 Lot 2
Inactivated Varicella Zoster Virus vaccine
V212 Lot 3
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
V212 Lot 3
Inactivated Varicella Zoster Virus vaccine
Interventions
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V212 Lot 1
Inactivated Varicella Zoster Virus vaccine
V212 Lot 2
Inactivated Varicella Zoster Virus vaccine
V212 Lot 3
Inactivated Varicella Zoster Virus vaccine
Eligibility Criteria
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Inclusion Criteria
* Any underlying chronic illness that is not in stable condition
* History of varicella, antibodies to VZV, or residence (for \>=30 years) in a country with endemic VZV infection
* Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation
* Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination
Exclusion Criteria
* Prior history of herpes zoster
* History of receipt or expects to receive any varicella or zoster vaccine during the study period
* Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination
* Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study
* Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination
* Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study
* Has participated in an investigational drug or vaccine study within 30 days before enrollment
* Has any acute illness or significant underlying illness that may interfere with interpretation of the study
* Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids
* Has known or suspected immune dysfunction
50 Years
59 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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de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
Other Identifiers
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2014-001030-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V212-014
Identifier Type: -
Identifier Source: org_study_id
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