Phase 3
N=368
A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00130793 ↗Enrolled (actual)
368
Serious AEs
0.3%
Results posted
Jul 2009
Primary outcome: Primary: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination — 717.5; 844.9 gpELISA units/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation (Biological); Comparator: zoster vaccine live (Oka/Merck) frozen formulation (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination |
717.5; 844.9 | — |
| SECONDARY Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination |
0; 0; 180; 183 | — |
Summary
The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.
Eligibility Criteria
Inclusion Criteria
- Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)
Exclusion Criteria
- Prior history of herpes zoster (shingles)
- Prior receipt of varicella or zoster vaccine
- Immunosuppressed
Data sourced from ClinicalTrials.gov (NCT00130793). 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.