Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

March 15, 2017 updated by: Merck Sharp & Dohme LLC

Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™

This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All Groups:

    • Must not have a fever of ≥100.4° F on the day of vaccination
    • Any underlying chronic illness must be in stable condition
    • History of varicella or residence in a VZV-endemic area for ≥30 years

  • Group 1:

    • 70 years of age or older
    • Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study

  • Group 2:

    • 70 years of age or older

  • Group 3:

    • 60 to 69 years of age

  • Group 4:

    • 50 to 59 years of age

Exclusion Criteria:

  • All Groups:

    • History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
    • Prior history of herpes zoster
    • Pregnant or breast-feeding, or expecting to conceive within the duration of the study
    • Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
    • Received any other vaccine within 4 weeks prevaccination
    • On immunosuppressive therapy
    • Has known or suspected immune dysfunction
    • Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.

  • Groups 2, 3, and 4:

    • Has previously received any varicella or zoster vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Booster Dose Participants ≥70 years of age
Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)
Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™
Experimental: Group 2: First Dose Participants ≥70 years of age
Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age
Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™
Experimental: Group 3: First Dose Participants ≥60 and <70 years of age
Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live
Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™
Experimental: Group 4: First Dose Participants ≥50 and <60 years of age
Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live
Biological: Zoster Vaccine, Live
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Other Names:
  • V211
  • ZOSTAVAX™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
Time Frame: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Day 1 (Baseline) and Week 6 postvaccination
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
Time Frame: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
Day 1 (Baseline) and Week 6 postvaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting One or More Adverse Experiences
Time Frame: Up to 42 days postvaccination
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.
Up to 42 days postvaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

University of Colorado, Denver
Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V211-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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