Clinical trial NCT00550745: ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
Official title: A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 11999
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Serious Adverse Events Reported Within 42 Days Postvaccination
timeFrame: 42 Days
Secondary outcomes:
measure: Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, Xu J, Wang WW, Chan IS, Annunziato PW, Parrino J. Safety and tolerability of zoster vaccine in adults >/=60 years old. Hum Vaccin. 2011 Nov;7(11):1130-6. doi: 10.4161/hv.7.11.17982. Epub 2011 Nov 1.