Clinical trial NCT02519855: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 882
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody
timeFrame: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
measure: Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers
timeFrame: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
measure: Geometric Mean Titers of H1N1-specific Influenza Virus Antibody
timeFrame: Baseline and 4 weeks after Influenza vaccination (Week 4)
measure: Geometric Mean Titers of H3N2-specific Influenza Virus Antibody
timeFrame: Baseline and 4 weeks after Influenza vaccination (Week 4)
measure: Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody
timeFrame: Baseline and 4 weeks after Influenza vaccination (Week 4)
measure: Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody
timeFrame: Baseline and 4 weeks after Influenza vaccination (Week 4)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.