drugset / Trial / NCT00696709
A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study was to assess the safety and tolerability of gamma-irradiated varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) and to determine if they were immunogenic when administered to healthy individuals, as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine would elicit an acceptable VZV-specific immune response.
Timeline
- Start
- 2008-12-12
- Primary completion
- 2009-11-16
- Completion
- 2009-11-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | V212 | Vaccine | 0.65 ml | Subcutaneous |