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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Colorado, Denver
Duke University
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01245751
First received: November 19, 2010
Last updated: July 21, 2014
Last verified: July 2014

November 19, 2010
July 21, 2014
April 2011
July 2012   (final data collection date for primary outcome measure)
  • Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) [ Time Frame: Week 6 postvaccination ] [ Designated as safety issue: No ]
    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
  • Geometric Mean Fold Rise (GMFR) From Day 1 to Week 6 Postvaccination in VZV Antibody Titers [ Time Frame: Day 1 and Week 6 postvaccination ] [ Designated as safety issue: No ]
    VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
  • Geometric mean titer (GMT) of the antibody responses to Varicella Zoster Virus (VZV) [ Time Frame: Week 4 post-vaccination ] [ Designated as safety issue: No ]
  • Geometric mean fold rise (GMFR) in VZV antibody titers [ Time Frame: Baseline to Week 4 post-vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01245751 on ClinicalTrials.gov Archive Site
Number of Participants Reporting One or More Adverse Experiences [ Time Frame: Up to 42 days postvaccination ] [ Designated as safety issue: Yes ]

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.

Not Provided
Not Provided
Not Provided
 
Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
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 is being conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information will be compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who are receiving their first dose of Zoster Vaccine, Live. The study will 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.

After completion of the 42-day postvaccination period, participants in Groups 3 and 4 will have 1 year postvaccination follow-up and participants in Groups 1 and 2 will have 3 years postvaccination follow-up.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Herpes Zoster
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 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 (NCT00007501)
    Intervention: Biological: Zoster Vaccine, Live
  • Active Comparator: 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
    Intervention: Biological: Zoster Vaccine, Live
  • Active Comparator: 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
    Intervention: Biological: Zoster Vaccine, Live
  • 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
    Intervention: Biological: Zoster Vaccine, Live
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
May 2015
July 2012   (final data collection date for primary outcome measure)

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) (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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01245751
V211-029
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
  • University of Colorado, Denver
  • Duke University
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP