Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age
2 other identifiers
interventional
22,439
0 countries
N/A
Brief Summary
This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
May 2, 2011
CompletedApril 12, 2017
March 1, 2017
2.3 years
September 21, 2007
January 4, 2011
March 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
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.
2 Years
Secondary Outcomes (2)
Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group
6 Weeks
Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period
Through 42 days post-vaccination
Study Arms (2)
Zostavax™
EXPERIMENTALParticipants randomized to receive Zoster Vaccine, Live (Zostavax™).
Placebo
PLACEBO COMPARATORParticipants randomized to receive Placebo.
Interventions
A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Gilbert PB, Gabriel EE, Miao X, Li X, Su SC, Parrino J, Chan IS. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis. 2014 Nov 15;210(10):1573-81. doi: 10.1093/infdis/jiu279. Epub 2014 May 13.
PMID: 24823623DERIVEDLevin MJ, Schmader KE, Gnann JW, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Varicella-zoster virus-specific antibody responses in 50-59-year-old recipients of zoster vaccine. J Infect Dis. 2013 Nov 1;208(9):1386-90. doi: 10.1093/infdis/jit342. Epub 2013 Aug 1.
PMID: 23908486DERIVEDSchmader 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. doi: 10.1093/cid/cir970. Epub 2012 Jan 30.
PMID: 22291101DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President of Late Stage Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2007
First Posted
September 24, 2007
Study Start
October 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
April 12, 2017
Results First Posted
May 2, 2011
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php