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)
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)
1 other identifier
interventional
882
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedStudy Start
First participant enrolled
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2016
CompletedResults Posted
Study results publicly available
February 14, 2017
CompletedOctober 30, 2018
October 1, 2018
5 months
August 7, 2015
December 22, 2016
October 1, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody
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
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
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
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
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
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)
Study Arms (2)
Concomitant Vaccination
EXPERIMENTALZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
Nonconcomitant Vaccination
EXPERIMENTALInfluenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
Interventions
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)
A single open-label administration of 0.5 mL intramuscular injection on Day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Levin MJ, Buchwald UK, Gardner J, Martin J, Stek JE, Brown E, Popmihajlov Z. Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine. Vaccine. 2018 Jan 2;36(1):179-185. doi: 10.1016/j.vaccine.2017.08.029. Epub 2017 Aug 19.
PMID: 28830693RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 11, 2015
Study Start
September 11, 2015
Primary Completion
January 26, 2016
Study Completion
January 26, 2016
Last Updated
October 30, 2018
Results First Posted
February 14, 2017
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf