NCT00546819CompletedPhase 2
A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 309
- Primary Endpoint
- Number of Participants With Serious Adverse Events (SAE)
Study Overview
Brief Summary
The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ZOSTAVAX™
Experimental
Participants administered ZOSTAVAX™ on Day 1.
Intervention: Zoster Vaccine, Live (Biological)
Placebo
Placebo Comparator
Participants administered Placebo on Day 1.
Intervention: Comparator: Placebo (Biological)
Outcomes
Primary Outcomes
Number of Participants With Serious Adverse Events (SAE)
Time Frame: 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 Outcomes
- Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination(42 days postvaccination)
- Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.(42 days postvaccination)
Investigators
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