A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

Herpes Zoster Clinical Trial

Official title:

A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130793
• Other study ID #: V211-010
• Secondary ID: 2005_035
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2005
• Last updated: January 14, 2015
• Start date: August 2005
• Est. completion date: November 2005

Study information

• Verified date: January 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

The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

Description:

The duration of treatment is 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)

Exclusion Criteria:

• Prior history of herpes zoster (shingles)

• Prior receipt of varicella or zoster vaccine

• Immunosuppressed

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
• Comparator: zoster vaccine live (Oka/Merck) frozen formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Gilderman LI, Lawless JF, Nolen TM, Sterling T, Rutledge RZ, Fernsler DA, Azrolan N, Sutradhar SC, Wang WW, Chan IS, Schlienger K, Schödel F, Silber JL; Zostavax Protocol 010 Study Group. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax. Clin Vaccine Immunol. 2008 Feb;15(2):314-9. Epub 2007 Dec 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination	GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination	From prevaccination (baseline) to 4 weeks postvaccination	No
Primary	Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination	The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.	4 weeks	No
Secondary	Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination	Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	4 weeks	Yes