drugset / Trial / NCT01626794
A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.
Timeline
- Start
- 2014-07
- Primary completion
- 2015-10
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | VARIVAX™ 2007 Process | Unknown | 0.5 ml | Subcutaneous |
| Subject | VARIVAX™ VEP | Unknown | 0.5 ml | Subcutaneous |
| Background | M-M-R II | Vaccine | — | — |