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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: Placebo to ZOSTAVAX™; Biological: ZOSTAVAX™; Biological: Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02519855

V211-062

Details and patient eligibility

About

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.

Enrollment: 882 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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882 participants in 2 patient groups

Concomitant Vaccination

Experimental group

Description:

ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4

Treatment:

Biological: Placebo to ZOSTAVAX™

Biological: Influenza Vaccine

Biological: ZOSTAVAX™

Nonconcomitant Vaccination

Experimental group

Description:

Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4

Treatment:

Biological: Placebo to ZOSTAVAX™

Biological: Influenza Vaccine

Biological: ZOSTAVAX™