Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
|ClinicalTrials.gov Identifier: NCT00534248|
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : May 2, 2011
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Shingles||Biological: Zoster Vaccine, Live (Zostavax™) Biological: Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22439 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Participants randomized to receive Zoster Vaccine, Live (Zostavax™).
Biological: Zoster Vaccine, Live (Zostavax™)
A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
Placebo Comparator: Placebo
Participants randomized to receive Placebo.
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.
- Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group [ Time Frame: 2 Years ]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.
- Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group [ Time Frame: 6 Weeks ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534248
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|