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)

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.

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