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ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

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ClinicalTrials.gov Identifier: NCT00546819
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : August 15, 2011
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE October 17, 2007
First Posted Date  ICMJE October 19, 2007
Results First Submitted Date  ICMJE July 20, 2011
Results First Posted Date  ICMJE August 15, 2011
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to 182 days postvaccination ]
A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2007)
This is an estimation study with no hypothesis testing
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
  • Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination [ Time Frame: 42 days postvaccination ]
    The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).
  • Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination. [ Time Frame: 42 days postvaccination ]
    The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)
Official Title  ICMJE A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids
Brief Summary The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Herpes Zoster
Intervention  ICMJE
  • Biological: Zoster Vaccine, Live
    A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1
    Other Name: V211
  • Biological: Comparator: Placebo
    A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.
Study Arms  ICMJE
  • Experimental: ZOSTAVAX™
    Participants administered ZOSTAVAX™ on Day 1.
    Intervention: Biological: Zoster Vaccine, Live
  • Placebo Comparator: Placebo
    Participants administered Placebo on Day 1.
    Intervention: Biological: Comparator: Placebo
Publications * Russell AF, Parrino J, Fisher CL Jr, Spieler W, Stek JE, Coll KE, Su SC, Xu J, Li X, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects on chronic/maintenance corticosteroids. Vaccine. 2015 Jun 17;33(27):3129-34. doi: 10.1016/j.vaccine.2015.04.090. Epub 2015 May 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2011)
309
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2007)
300
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Varicella-history positive, herpes zoster (HZ)-history negative patients
  • 60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period)
  • All females enrolling must be postmenopausal

Exclusion Criteria:

  • Patients with a history of hypersensitivity reaction to gelatin or neomycin
  • Prior receipt of varicella or zoster vaccine; prior history of herpes zoster
  • Immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period
  • Receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment
  • Known immune deficiency that is caused by a medical condition
  • Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses
  • Concomitant use of antiviral therapy
  • A history of alcohol abuse or recreational drug use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   France,   Germany,   Puerto Rico,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00546819
Other Study ID Numbers  ICMJE V211-017
2006_557
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP