Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)

This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster; Shingles
• Intervention / Treatment: Biological: Zoster Vaccine, Live (AMP); Biological: Zoster Vaccine, Live

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No fever on day of vaccination
• History of varicella or residence in a VZV-endemic area for ≥30 years
• Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion Criteria:

• History of hypersensitivity reaction to any vaccine component
• Prior receipt of any varicella or zoster vaccine
• Prior history of herpes zoster
• Have recently had another vaccination
• Pregnant or breastfeeding
• Use of immunosuppressive therapy
• Known or suspected immune dysfunction
• Concomitant antiviral therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZOSTAVAX™ (AMP); ZOSTAVAX™ manufactured with an alternative process	Biological: Zoster Vaccine, Live (AMP); One approximately 0.65-mL injection subcutaneously on Day 1
Active Comparator: ZOSTAVAX™; ZOSTAVAX™ manufactured with the current process	Biological: Zoster Vaccine, Live; One approximately 0.65-mL injection subcutaneously on Day 1; Other Names: V211; ZOSTAVAX™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody	VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)	Day 1 and Week 6 postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers	VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).	Day 1 (Baseline) to Week 6 postvaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Adverse Experiences (AEs)	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.	Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination	An SAE 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	Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination	An SAE 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	Day 1 to Day 182 postvaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 4, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V211-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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