A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

Herpes Zoster Clinical Trial

Official title:

A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322231
• Other study ID #: V211-014
• Secondary ID: 2006_010
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2006
• Last updated: January 14, 2015
• Start date: May 2006
• Est. completion date: July 2007

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Adults = 50 years of age with a history of herpes zoster = 5 years prior to enrollment

Exclusion Criteria:

• History of allergy to any vaccine component

• Prior receipt of a varicella or zoster vaccine

• Ability to defend against infection is suppressed by a medical condition or medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• zoster vaccine live (ZOSTAVAX™)
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
• Comparator: Placebo
1 dose 0.65 mL/dose subcutaneous injection of placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.va — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination	SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event	To Day 28 postvaccination	Yes
Secondary	Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination	The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination	4 weeks postvaccination	No
Secondary	Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination	GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination	From prevaccination (baseline) to 4 weeks postvaccination	No