A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly with Influenza Virus Vaccine (Inactivated) - ZOSTAVAX™ Administered Concomitantly with Influenza Vaccine
- Conditions
- Herpes ZosterMedDRA version: 8.0Level: LLTClassification code 10019974
- Registration Number
- EUCTR2005-003035-52-DE
- Lead Sponsor
- Merck & Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 372
• Age = 50 years
• Signed inform consent prior to any study procedure
• Afebrile (<101.0°F [<38.3°C]) oral or equivalent on day of vaccination.
• Any underlying chronic illness must be in stabilized.
• All females must be postmenopausal or have a negative serum or urine pregnancy test
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
•History of hypersensitivity reaction to any vaccine component, including gelatine, neomycin, egg proteins, or chicken proteins
•Prior history of HZ
•Prior history of any varicella or zoster vaccine
•Subject is pregnant or breastfeeding or expecting to conceive within projected duration of the study.
•Immunoglobulin or nay blood products administered or scheduled in the period from 5 months prior to vaccination through Visit 3
•Any live virus vaccine administered or scheduled in the period from 4 weeks prior to vaccination through Visit 3.
•Any inactivated vaccine administered or scheduled in the period from 7 days prior to vaccination through Visit 3.
•Participation in an investigational drug or vaccine study within the last 30 days prevaccination.
•Any acute intercurrent illness that might interfere with the interpretation of the study.
•Significant underlying illness preventing completion of the study.
•Use of immunosuppressive therapy.
• Known or suspected immune dysfunction that is caused by a medical condition, or any other cause.
• Any concomitant use of nontopical antiviral therapy with activity against herpes viruses.
• A history of alcohol abuse or recreational drug use which, in the opinion of the investigator, will interfere with study participation.
• Any influenza vaccine administered for the 2005-2006 flu season.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method