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

Phase 2

Completed

• Conditions: Herpes Zoster
• Interventions: Biological: Zoster Vaccine, Live

• Registration Number: NCT00546819
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-19
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2011-07-20
• Results First Submitted QC: 2011-07-20
• Results First Posted: 2011-08-15
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZOSTAVAX™	Zoster Vaccine, Live	Participants administered ZOSTAVAX™ on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events (SAE)	Up to 182 days postvaccination	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

Name	Time	Method
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination	42 days postvaccination	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.	42 days postvaccination	The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.