Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534248
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|