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

Phase 3

Completed

• Conditions: Herpes Zoster; Shingles
• Interventions: Biological: Zoster Vaccine, Live; Biological: Zoster Vaccine, Live (AMP)

• Registration Number: NCT01505647
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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™.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-06
• Study Start: 2012-04
• Primary Completion: 2012-07
• Study Completion: 2012-11
• Results First Submitted: 2013-04-10
• Results First Submitted QC: 2013-07-01
• Results First Posted: 2013-07-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZOSTAVAX™	Zoster Vaccine, Live	ZOSTAVAX™ manufactured with the current process
ZOSTAVAX™ (AMP)	Zoster Vaccine, Live (AMP)	ZOSTAVAX™ manufactured with an alternative process

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody	Day 1 and Week 6 postvaccination	VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers	Day 1 (Baseline) to Week 6 postvaccination	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination	Day 1 to Day 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
Number of Participants With One or More Adverse Experiences (AEs)	Day 1 to Day 42 postvaccination	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.
Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination	Day 1 to Day 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