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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-14

Study Completion Date

2008-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Herpes Zoster

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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All Enrolled

Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)

Group Type EXPERIMENTAL

ZOSTAVAX®

Intervention Type BIOLOGICAL

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

Interventions

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ZOSTAVAX®

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes