Herpes Zoster MedDRA version: 8.0 Level: LLT Classification code 10019974
Conditions
Interventions
Product Name: ZOSTAVAX™
Product Code: Not Applicable
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 50 years • Signed inform consent prior to any study procedure • Afebrile (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety and tolerability of ZOSTAVAX™ when administered concomitantly with influenza vaccine in subjects 50 years of age or older.;Main Objective: 1) To determine whether ZOSTAVAX™ administered concomitantly with influenza vaccine in subjects 50 years of age or older elicits a VZV antibody response that is noninferior to that of ZOSTAVAX™ administered alone. 2) To demonstrate whether ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with influenza vaccine in subjects 50 years of age or older. 3) To assess whether influenza vaccine administered concomitantly with ZOSTAVAX™ in subjects 50 years of age or older elicits strain-specific influenza antibody responses that are noninferior to those of influenza vaccine administered alone. ;Primary end point(s): • The primary immunogenicity endpoints are the geometric mean titers (GMTs) of VZV antibodies by gpELISA and GMTs of the strain-specific influenza antibodies by HAI for each of the 3 strains contained in the influenza vaccine at 4 weeks postvaccination. • The endpoint for the acceptance hypothesis is the geometric mean fold rise (GMFR) of VZV antibody titers from prevaccination to week 4 postvaccination in the concomitant group | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed