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)

October 1, 2018 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

882

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:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Fluzone, Vaxigrip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
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.
Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
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.
Baseline and 4 weeks after Influenza vaccination (Week 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.
Baseline and 4 weeks after Influenza vaccination (Week 4)
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.
Baseline and 4 weeks after Influenza vaccination (Week 4)
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.
Baseline and 4 weeks after Influenza vaccination (Week 4)

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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 (Actual)

September 11, 2015

Primary Completion (Actual)

January 26, 2016

Study Completion (Actual)

January 26, 2016

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V211-062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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