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)

Phase 3CompletedNCT02519855

Merck Sharp & Dohme LLC882 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

882

Conditions

Herpes Zoster

Interventions

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 4 weeks after Influenza vaccination (Week 4)