ZOSTAVAX™ Safety Study in Subjects ≥ 60… | Clinical Trial

Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoster Vaccine, Live

Biological

single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.

Comparator: Placebo

Biological

single 0.65 mL Placebo injection. 6 month treatment period.

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Oct 30, 2007
Registry last updated: Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed