NCT02180295

A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)

A Phase III, Double-Blind, Lot-To-Lot Consistency Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	V212 Lot 1	Inactivated Varicella Zoster Virus vaccine
BIOLOGICAL	V212 Lot 2	Inactivated Varicella Zoster Virus vaccine
BIOLOGICAL	V212 Lot 3	Inactivated Varicella Zoster Virus vaccine

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-07-02
• Last updated: 2015-08-13