Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00534248

First received: September 21, 2007

Last updated: March 31, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2007

Last Updated Date

March 31, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.

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

Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.
Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period [ Time Frame: Through 42 days post-vaccination ] [ Designated as safety issue: Yes ]
A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.

Original Secondary Outcome Measures ^ICMJE

Increase in antibody response at 6 weeks post vaccination.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

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 participants ages 50-59 years old.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Shingles

Intervention ^ICMJE

Biological: Zoster Vaccine, Live (Zostavax™)
A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
Other Names:
- V211
- Zostavax™
Biological: Comparator: Placebo
A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.

Study Arm (s)

Experimental: Zostavax™
Participants randomized to receive Zoster Vaccine, Live (Zostavax™).

Intervention: Biological: Zoster Vaccine, Live (Zostavax™)
Placebo Comparator: Placebo
Participants randomized to receive Placebo.

Intervention: Biological: Comparator: Placebo

Publications *

Schmader KE, Levin MJ, Gnann JW Jr, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis. 2012 Apr;54(7):922-8. Epub 2012 Jan 30.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

22439

Completion Date

January 2010

Primary Completion Date

January 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

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00534248

Other Study ID Numbers ^ICMJE

V211-022, 2007_551

Has Data Monitoring Committee

Not Provided

Responsible Party

Vice President of Late Stage Development, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2011

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

To Top