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

Herpes Zoster Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505647
• Other study ID #: V211-042
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2012
• Last updated: September 3, 2015
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: September 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 determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Herpes Zoster
• Shingles

Intervention

Biological:
• Zoster Vaccine, Live (AMP)
One approximately 0.65-mL injection subcutaneously on Day 1
• Zoster Vaccine, Live
One approximately 0.65-mL injection subcutaneously 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	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes