ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00546819

Purpose

The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.

Condition	Intervention	Phase
Herpes Zoster	Biological: Zoster Vaccine, Live Biological: Comparator: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Zostavax Corticosteroids

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to 182 days postvaccination ] [ Designated as safety issue: Yes ]
A serious adverse event is defined as 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:

Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination [ Time Frame: 42 days postvaccination ] [ Designated as safety issue: No ]
The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination. [ Time Frame: 42 days postvaccination ] [ Designated as safety issue: No ]
The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.

Enrollment:	309
Study Start Date:	October 2007
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ZOSTAVAX™ Participants administered ZOSTAVAX™ on Day 1.	Biological: Zoster Vaccine, Live A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1 Other Name: V211
Placebo Comparator: Placebo Participants administered Placebo on Day 1.	Biological: Comparator: Placebo A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Varicella-history positive, herpes zoster (HZ)-history negative patients
60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period)
All females enrolling must be postmenopausal

Exclusion Criteria:

Patients with a history of hypersensitivity reaction to gelatin or neomycin
Prior receipt of varicella or zoster vaccine; prior history of herpes zoster
Immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period
Receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment
Known immune deficiency that is caused by a medical condition
Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses
Concomitant use of antiviral therapy
A history of alcohol abuse or recreational drug use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546819

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00546819 History of Changes
Other Study ID Numbers:	V211-017, 2006_557
Study First Received:	October 17, 2007
Results First Received:	July 20, 2011
Last Updated:	July 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012