ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids - Full Text View

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

Purpose

The purpose of the study is to determine whether ZOSTAVAX™ is safe, generally well tolerated, and immunogenic in patients on chronic/maintenance corticosteroids.

Condition	Intervention	Phase
Herpes Zoster	Biological: Zoster Vaccine, Live, (Oka-Merck) Biological: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
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:

Safety and tolerability of ZOSTAVAX. This is an estimation study with no hypothesis [ Time Frame: 42 days for adverse events and 182 days for serious adverse events after receipt of ZOSTAVAX ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Varicella-Zoster Virus (VZV) antibody response at 42 days postvaccination and Geometric Fold Rise (GMFR) of VZV antibody response from Day 1 to Day 42 postvaccination. There is no hypothesis. [ Time Frame: 42 days postvaccination ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vaccine	Biological: Zoster Vaccine, Live, (Oka-Merck) single 0.65 ml subcutaneous injection Zoster Vaccine, Live, (Oka-Merck) at Day 1
2: Placebo Comparator Placebo	Biological: Comparator: Placebo single 0.65 ml subcutaneous Placebo injection at 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 during 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 post vaccination period)

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 post vaccination 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
All females enrolling must be postmenopausal
A history of alcohol abuse or recreational drug use

Contacts and Locations

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 30 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_557, V211-017
Study First Received:	October 17, 2007
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00546819 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Virus Diseases
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on February 04, 2010