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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550745
• Other study ID #: V211-020
• Secondary ID: 2007_606
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2007
• Last updated: June 2, 2015
• Start date: September 2007
• Est. completion date: January 2009

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11999
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• Zoster Vaccine, Live
single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.
• Comparator: placebo
single 0.65 mL Placebo injection. 6 month treatment period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events Reported Within 42 Days Postvaccination	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.	42 Days	Yes
Secondary	Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination	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.	6 months	Yes