A Phase III Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids - Study of Zoster vaccine in subjects on chronic steroid maintenance

Phase 1

• Conditions: Zoster Vaccine; MedDRA version: 8.1 Level: LLT Classification code 10019974 Term: Herpes zoster

• Registration Number: EUCTR2006-003651-20-GB
• Lead Sponsor: Merck & Co Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-04
• Study Completion: 2010-08-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Age=60 years.
2. A history of varicella or long-term residence in a country with endemic VZV infection.
3. Receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone or equivalent for at least 2 weeks immediately prior to enrolment.
4. Expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week duration of the study (dose may vary within this range during the 6-week postvaccination period).
5. All females mst be postmenopausal or have a negative serum or urine pregnancy test. A patient who is reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, oral contraceptive pills, condom, tubal ligation and vasectomy.
6. Signed consent form prior to any study procedure.
7. Any underlying chronic illness, including the condition for which the patient is receiving corticosteroids, must be in stable condition.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A histroy of allergic reaction to any vaccine component (including gelatin), or an anaphylactic/anaphylactoid reaction to neomycin (note that patients with history of contact dermatitis from neomycin may receive the vaccine.)
2. Prior history of HZ
3. Prior receipt of any varicella or zoster vaccine.
4. Women who are pregnant or breast feeding or planning to conceive within projected duration of the study.
5. Any use in the 8 weeks prior to vaccination or expected for 6 weeks postvaccination of concomitant immunosuppressive medications (e.g. corticosteroids >20 mg daily, chemotherapeutic agents, immunomodulating drugs, immunosuppressive treatments associated with solid organ or bone marrow transplantation.
6. Known or suspected immune dysfunction that is casued by a medical condition (other than that for which patient is receiving corticosteroid therapy), or any cause.
7. Immunoglobulin or any blood products, other than autologous blood tranfusion, given during the 5 months prior to vaccination or expected during the 6-week postvaccination period.
8. Any other live virus vaccine administered or scheduled from 4 weeks prior to vaccination or expected during the 6 week primary safety follow-up period.
9. Any inactivated vaccine adminsitered or scheduled in the period from 7 days prior to vaccination or expected during the 6-week primary safety follow-up period.
10. participation in an investigational drug or vaccine study within the last 30 days prior to enrollment and for 6-month safety follow-up period.
11. Any acute intercurrent illness that might interfere with the study such as unstable systemic lupus ewrythmetosus or unstable multiple sclerosis.
12. Significant underlying illness preventing completion of the study.
13. Any concomitatn use of nontopical antiviral therapy with activity against herpesviruses, including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscaernet and cidofovir.
14. a history of alcohol abuse or recreational drug use, which, in the opinion of the investigator, will interfere with study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Main objective: To determine whether ZOSTAVAX™ [zoster vaccine live (Oka/Merck)] has acceptable safety profile when administered to patients who are receiving chronic/maintenance corticosteroid therapy.<br><br> ;<br> Secondary Objective: Secondary objective: To determine whether ZOSTAVAX™ [zoster vaccine live (Oka/Merck)] is immunogenic when administered to patients who are receiving chronic/maintenance corticosteroid therapy.<br><br><br> ;Primary end point(s): Safety of the Vaccine.