Phase 4
N=180
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
Herpes Zoster · Shingles
Bottom Line
View on ClinicalTrials.gov: NCT01556451 ↗Enrolled (actual)
180
Serious AEs
1.7%
Results posted
Sep 2013
Primary outcome: Primary: Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody — 2.8 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zoster Vaccine Live (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody |
2.8 | — |
| PRIMARY Geometric Mean Titer (GMT) of VZV Antibody |
66.9; 185.4 | — |
| PRIMARY Percentage of Participants With Clinical Adverse Experiences |
53.3; 24.4 | — |
| PRIMARY Percentage of Participants Discontinued Due to Clinical Adverse Experiences |
— | — |
Summary
This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.
Eligibility Criteria
Inclusion Criteria
- No fever on day of vaccination
- Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
- Underlying chronic illness must be stable
Exclusion Criteria
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster
- Prior receipt of varicella or zoster vaccine
- Pregnant or breastfeeding
- Have recently received immunoglobulins or blood products other than autologous blood transfusion
- Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study
- Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study
- Use of immunosuppressive therapy
- Known or suspected immune dysfunction
- Use of nontopical antiviral therapy with activity against herpes virus
- Known or suspected active untreated tuberculosis
Data sourced from ClinicalTrials.gov (NCT01556451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.