NCT00681031

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2008

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2008

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

September 26, 2017

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

May 16, 2008

Results QC Date

August 29, 2017

Last Update Submit

June 28, 2021

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

All Enrolled

EXPERIMENTAL

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

Biological: ZOSTAVAX®

Interventions

ZOSTAVAX®BIOLOGICAL

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

All Enrolled

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21941091DERIVED

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

May 14, 2008

Primary Completion

June 25, 2008

Study Completion

June 25, 2008

Last Updated

June 29, 2021

Results First Posted

September 26, 2017

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

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

More information