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

Primary Purpose

Herpes Zoster

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

ZOSTAVAX®

About this trial

This is an interventional prevention trial for Herpes Zoster

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Enrolled

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00681031

First Posted

May 16, 2008

Last Updated

June 28, 2021

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00681031

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

May 14, 2008 (Actual)

Primary Completion Date

June 25, 2008 (Actual)

Study Completion Date

June 25, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Zoster

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All Enrolled

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

ZOSTAVAX®

Intervention Description

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

Primary Outcome Measure Information:

Title

Geometric Mean Titre (GMT) of Varicella Antibodies

Description

Time Frame

Predose (Day 0) and Day 28-35 Post Dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

21941091

Citation

Arnou R, Fiquet A, Thomas S, Sadorge C. Immunogenicity and safety of ZOSTAVAX((R)) approaching expiry potency in individuals aged >/=50 years. Hum Vaccin. 2011 Oct;7(10):1060-5. doi: 10.4161/hv.7.10.16480. Epub 2011 Oct 1.

Results Reference

derived

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

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