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ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00550745
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : February 2, 2010
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: Zoster Vaccine, Live Biological: Comparator: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11999 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age
Study Start Date : September 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: 1
Arm 1: vaccine
Biological: Zoster Vaccine, Live
single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.

Placebo Comparator: 2
Arm 2: Placebo Comparator
Biological: Comparator: placebo
single 0.65 mL Placebo injection. 6 month treatment period.




Primary Outcome Measures :
  1. Serious Adverse Events Reported Within 42 Days Postvaccination [ Time Frame: 42 Days ]

    Only Serious Adverse Events were collected and analyzed for this

    study.

    A serious adverse event is 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.



Secondary Outcome Measures :
  1. Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination [ Time Frame: 6 months ]

    Only Serious Adverse Events were collected and analyzed for this study.

    A serious adverse event is 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.




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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60+ years of Age
  • Signed an informed consent prior to the start of study
  • Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
  • Females must be postmenopausal or have a negative pregnancy test

Exclusion Criteria:

  • A history of allergic reaction to any vaccine component (including gelatin or neomycin)
  • Prior receipt of any varicella or zoster vaccine
  • Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
  • Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
  • Subject is pregnant or breastfeeding
  • Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination
  • An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study
  • Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation
  • Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible
  • Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550745


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00550745     History of Changes
Other Study ID Numbers: V211-020
2007_606
First Posted: October 30, 2007    Key Record Dates
Results First Posted: February 2, 2010
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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

Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs