drugset / Trial / NCT00696709

A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

NCT00696709

Phase 1 Completed 290 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject V212 Vaccine 0.65 ml Subcutaneous

Indications