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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00681031
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: ZOSTAVAX® Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : May 31, 2008
Actual Primary Completion Date : June 30, 2008
Actual Study Completion Date : October 31, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Biological: ZOSTAVAX®
One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Titre (GMT) of Varicella Antibodies [ Time Frame: Predose (Day 0) and Day 28-35 Post Dose ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681031


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00681031     History of Changes
Other Study ID Numbers: V211-044
ZTV02C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
2007-006532-66 ( EudraCT Number )
First Posted: May 20, 2008    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases