Phase 3
N=101
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00322231 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination — 0; 0; 100; 101 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- zoster vaccine live (ZOSTAVAX™) (Biological); Comparator: Placebo (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination |
0; 0; 100; 101 | — |
| SECONDARY Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination |
810.1; 391.1 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination |
2.1; 1.0 | — |
Summary
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
Eligibility Criteria
Inclusion Criteria
- Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
Exclusion Criteria
- History of allergy to any vaccine component
- Prior receipt of a varicella or zoster vaccine
- Ability to defend against infection is suppressed by a medical condition or medication
Data sourced from ClinicalTrials.gov (NCT00322231). 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.