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

Shingles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534248
• Other study ID #: V211-022
• Secondary ID: 2007_551
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2007
• Last updated: August 11, 2015
• Start date: October 2007
• Est. completion date: January 2010

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22439
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 59 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Shingles

Intervention

Biological:
• Zoster Vaccine, Live (Zostavax™)
A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group	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.	6 Weeks	No
Secondary	Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period	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.	Through 42 days post-vaccination	Yes

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site