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Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)

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ClinicalTrials.gov Identifier: NCT02519855
Recruitment Status : Completed
First Posted : August 11, 2015
Results First Posted : February 14, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: ZOSTAVAX™ Biological: Placebo to ZOSTAVAX™ Biological: Influenza Vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III, Double-Blind, Randomized, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated)
Actual Study Start Date : September 11, 2015
Actual Primary Completion Date : January 26, 2016
Actual Study Completion Date : January 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Flu Flu Shot Shingles

Arm Intervention/treatment
Experimental: Concomitant Vaccination
ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
Biological: ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
Other Name: V211

Biological: Placebo to ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)

Biological: Influenza Vaccine
A single open-label administration of 0.5 mL intramuscular injection on Day 1
Other Name: Fluzone, Vaxigrip

Experimental: Nonconcomitant Vaccination
Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
Biological: ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
Other Name: V211

Biological: Placebo to ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)

Biological: Influenza Vaccine
A single open-label administration of 0.5 mL intramuscular injection on Day 1
Other Name: Fluzone, Vaxigrip




Primary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody [ Time Frame: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group) ]
    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.

  2. Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers [ Time Frame: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group) ]
    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.

  3. Geometric Mean Titers of H1N1-specific Influenza Virus Antibody [ Time Frame: Baseline and 4 weeks after Influenza vaccination (Week 4) ]
    Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

  4. Geometric Mean Titers of H3N2-specific Influenza Virus Antibody [ Time Frame: Baseline and 4 weeks after Influenza vaccination (Week 4) ]
    Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

  5. Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody [ Time Frame: Baseline and 4 weeks after Influenza vaccination (Week 4) ]
    Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

  6. Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody [ Time Frame: Baseline and 4 weeks after Influenza vaccination (Week 4) ]
    Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.



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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:

  • Has history of varicella or residence in a VZV-endemic area for ≥30 years
  • Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study

Exclusion Criteria:

  • Has history of hypersensitivity to any vaccine component
  • Has previously received any varicella or zoster vaccine
  • Has received an influenza vaccine for the 2015-16 season
  • Has history of Herpes zoster
  • Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
  • Is pregnant or breastfeeding, or expecting to conceive during the study
  • Has used immunosuppressant therapy
  • Has known or suspected immune dysfunction
  • Has experienced Guillain-Barré syndrome within 6 weeks
  • Has severe thrombocytopenia or any other coagulation disorder

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): NCT02519855


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02519855    
Other Study ID Numbers: V211-062
First Posted: August 11, 2015    Key Record Dates
Results First Posted: February 14, 2017
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases