MedTrace Logo

Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

NCT00681031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-06-29

Study results available
· View outcomes & findings →

Summary

Primary objective:

To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay \[gpELISA\]) from pre-vaccination to 4 weeks post-vaccination.

Secondary objectives:

To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

ZOSTAVAX®

One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-14
Primary Completion
2008-06-25
Completion
2008-06-25
FDA Drug
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00681031 on ClinicalTrials.gov