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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Herpes Zoster

Treatments

Biological: ZOSTAVAX®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00681031

V211-044

ZTV02C (Other Identifier)

2007-006532-66 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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