Phase 3
Completed 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)
Source: ClinicalTrials.gov NCT00130793 ↗Enrolled (actual)
368
Serious AEs
0.3%
Results posted
Jul 2009
Primary outcomePrimary: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination — 717.5; 844.9 gpELISA units/mL
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.
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 | — |
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. Informational only — not medical advice.