Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

Herpes Zoster Clinical Trial

Official title:

An Open-label, Single-arm, Phase IV Study Assessing the Immunogenicity and Safety of ZOSTAVAX® at Minimum Release Specification Approaching Expiry Potency in Subjects ≥50 Years Old.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681031
• Other study ID #: V211-044
• Secondary ID: ZTV02C2007-00653
• Status: Completed
• Phase: Phase 4
• Start date: May 14, 2008
• Est. completion date: June 25, 2008

Study information

• Verified date: June 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective:

To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay [gpELISA]) from pre-vaccination to 4 weeks post-vaccination.

Secondary objectives:

To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 25, 2008
• Est. primary completion date: June 25, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Participant of either gender aged =50 years

• Positive history of varicella or residence for >30 years in a country with endemic VZV infection

• All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination

• Participant having signed the informed consent form prior to any study procedure

Exclusion Criteria:

• Febrile within 72 hours prior to vaccination

• Prior history of Herpes Zoster clinically diagnosed by a physician

• Previously received a varicella or zoster vaccine

• Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination

• Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study

• Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study

• Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study

• Taking any non topical antiviral therapy with activity against herpesviruses.

• On immunosuppressive therapy

• Known or suspected immune dysfunction caused by a medical condition, or any other cause

• History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin

• Known active tuberculosis

• Significant underlying illness preventing completion of the study

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• ZOSTAVAX®
One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU

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 Titre (GMT) of Varicella Antibodies	Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).	Predose (Day 0) and Day 28-35 Post Dose