Study to Evaluate the Safety and Effectiveness of Zostavax® in Subjects 50 - 59 Years of Age - Tabular View

Tracking Information

First Received Date ^ICMJE

September 21, 2007

Last Updated Date

November 12, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Vaccine efficacy [ Time Frame: 2.5 Years ] [ 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

Vaccine efficacy

Change History

Complete list of historical versions of study NCT00534248 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Increase in antibody response at 6 weeks post vaccination. [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Increase in antibody response at 6 weeks post vaccination.

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate the Safety and Effectiveness of Zostavax® in Subjects 50 - 59 Years of Age

Official Title ^ICMJE

A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax® in Subjects 50-59 Years of Age

Brief Summary

This study will look at how well Zostavax® works in preventing shingles in people ages 50-59 years old.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Shingles

Intervention ^ICMJE

Biological: Zoster Vaccine, Live, (Oka-Merck)
Biological: Comparator: placebo (unspecified)

Study Arms / Comparison Groups

Experimental: Arm 1: vaccine
Placebo Comparator: Arm 2: Pbo 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

22300

Estimated Completion Date

May 2010

Estimated Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must be between 50 - 59 years of age
No fever on day of vaccination
Females of reproductive potential must be willing to use acceptable form of birth control

Exclusion Criteria:

Have received chicken pox or shingles vaccine
Have already had shingles
Have recently had another vaccination
Pregnant or breast feeding. Have participated in another research study in the last 30 days
You are taking certain antiviral drugs
History of allergic reaction to any vaccine component, including gelatin or neomycin

Gender

Both

Ages

50 Years to 59 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00534248

Responsible Party

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

Study ID Numbers ^ICMJE

2007_551, V211-022

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

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