A Study of an Investigational V212/Heat-Treated VZV Vaccine in Immunocompromised Adults - Tabular View

Tracking Information

First Received Date ^ICMJE

September 25, 2007

Last Updated Date

October 28, 2009

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Immunogenicity of V212 when administered to immunocompromised patients [ Time Frame: 28 days postdose 4 ] [ Designated as safety issue: No ]
To assess varicella zoster virus (VZV) vaccine safety and tolerability [ Time Frame: through 28 days postdose 4 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Immunogenicity of V212 when administered to immunocompromised patients. [ Time Frame: 125 Days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00535236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability of V212 in immunocompromised patients [ Time Frame: 28 days post dose 4 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability of V212 in immunocompromised patients. [ Time Frame: 125 Days ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

A Study of an Investigational V212/Heat-Treated VZV Vaccine in Immunocompromised Adults

Official Title ^ICMJE

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults

Brief Summary

The proposed indication for the investigational heat-treated varicella-zoster virus (VZV) vaccine is the prevention of herpes zoster (HZ) and HZ-related complications in immunocompromised individuals.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Herpes Zoster
Herpes Zoster-related Complications

Intervention ^ICMJE

Biological: Comparator: V212
Biological: Comparator: Placebo

Study Arms / Comparison Groups

Experimental: Arm 1: Vaccine
Placebo Comparator: Arm 2: Placebo Comparator

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

340

Estimated Completion Date

March 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic - Hematopoietic cell transplant within 60 days of enrollment
HIV-infected patients with a baseline CD4 cell count < or = to 200 cells/mm^3
Patients with hematologic malignancies
Patients who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies

Exclusion Criteria:

History of allergy to any vaccine component
Prior history of HZ
Prior history of receipt of any varicella or zoster vaccine

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00535236

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_608, V212-002

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP