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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 4

Conditions

Herpes Zoster

Treatments

Biological: Zoster Vaccine, Live
Biological: Comparator: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00550745
V211-020
2007_606

Details and patient eligibility

About

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.

Enrollment

11,999 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

11,999 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Arm 1: vaccine
Treatment:
Biological: Zoster Vaccine, Live
2
Placebo Comparator group
Description:
Arm 2: Placebo Comparator
Treatment:
Biological: Comparator: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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