A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011) - Full Text View

Purpose

The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.

Condition	Intervention	Phase
Herpes Zoster	Biological: ZOSTAVAX™ (concomitant) Biological: Comparator: Influenza Vaccine Biological: ZOSTAVAX™ (Nonconcomitant)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Flu Shingles

Drug Information available for: Herpes Zoster Vaccine Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.

Enrollment:	763
Study Start Date:	September 2005
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Concomitant Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4	Biological: ZOSTAVAX™ (concomitant) a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4 Other Name: V211 Biological: Comparator: Influenza Vaccine a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1 Other Name: Fluzone, Vaxigrip
Experimental: Nonconcomitant Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4	Biological: Comparator: Influenza Vaccine a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1 Other Name: Fluzone, Vaxigrip Biological: ZOSTAVAX™ (Nonconcomitant) Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adults 50 years of age or older

Exclusion Criteria:

Prior history of Herpes Zoster (shingles)
Prior receipt of varicella or zoster vaccine
Immunosuppressed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231816

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Kerzner B, Murray AV, Cheng E, Ifle R, Harvey PR, Tomlinson M, Barben JL, Rarrick K, Stek JE, Chung MO, Schodel FP, Wang WW, Xu J, Chan IS, Silber JL, Schlienger K. Safety and Immunogenicity Profile of the Concomitant Administration of ZOSTAVAX and Inactivated Influenza Vaccine in Adults Aged 50 and Older. J Am Geriatr Soc. 2007 Oct;55(10):1499-507.

Sutradhar SC, Wang WW, Schlienger K, Stek JE, Xu J, Chan IS, Silber JL. Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. Clin Vaccine Immunol. 2009 May;16(5):646-52. Epub 2009 Mar 4.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00231816 History of Changes
Other Study ID Numbers:	V211-011, 2005_036
Study First Received:	September 30, 2005
Results First Received:	May 12, 2010
Last Updated:	November 17, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Prevention of Herpes Zoster

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013