herpes zoster, pneumococcal infection MedDRA version: 9.1 Level: LLT Classification code 10019974 Term: Herpes zoster
Conditions
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 60 years or older 2. Signed an informed consent prior to any study procedures 3. Afebrile (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A history of allergic reaction to any vaccine component. 2. Prior history of herpes zoster or invasive/culture-positive pneumococcal disease. 3. Prior receipt of any pneumococcal, varicella or zoster vaccine. 4. Any acute intercurrent illness or significant underlying illness that may interfere with the interpretation of the study. 5. Subject is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. 6. Use of immunosuppressive therapy, known or suspected immune dysfunction that is caused by a medical condition or any other cause 7. Any concomitant use of nontopical antiviral therapy with activity against herpesviruses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety and tolerability of ZOSTAVAX™ and PNEUMOVAX™ 23 when administered concomitantly.;Main Objective: 1. To determine whether ZOSTAVAX™ administered concomitantly with PNEUMOVAX™ 23 elicits a VZV antibody response that is noninferior to that of ZOSTAVAX™ administered nonconcomitantly. 2. To demonstrate whether ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23. 3. To assess whether PNEUMOVAX™ 23 administered concomitantly with ZOSTAVAX™ elicits serotype-specific pneumococcal antibody responses for serotypes 3, 14, 19A, and 22F that are noninferior to those of PNEUMOVAX™ 23 administered nonconcomitantly ;Primary end point(s): Immunogenicity endpoints for varicella zoster virus (VZV) antibody responses: • geometric mean titer (GMT) 4 weeks postvaccination of ZOSTAVAX™ • geometric mean foldrise (GMFR) from prevaccination to 4 weeks postvaccination of ZOSTAVAX™ Immunogenicity endpoints for pneumococcal polysaccharide (PnPs) antibody responses - GMT 4 weeks postvaccination of PNEUMOVAX™ 23 Safety endpoints: • Tiered approach will be used to analyze specific adverse experiences o Tier 1: VRC-prompted VZV-like rash, noninjection-site, from Day 1 to Day 28 after each vaccination; and injection-site adverse experiences; VRC-prompted, Day 1 to Day 5 following each vaccination for primary analysis o Tier 2: adverse experiences that are not prompted for on the VRC but reported by =1% of subjects in either vaccination group o Tier 3: all other adverse experiences Day 1 to Day 28 following each vaccination will be summarized • Overall rate of serious adverse experiences o Day 1 to Day 28 following each vaccination for primary analysis (risk difference and 95% CI) o All serious adverse experiences will be reported and summarized from the time of enrollment through Visit 3 | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed