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)



Status:Completed
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:11/28/2015
Start Date:September 2015
End Date:February 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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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 will evaluate 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 will test the
non-inferiority of concomitant versus nonconcomitant vaccination with regard to 1) Varicella
zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses and 2) influenza virus
strain-specific GMT antibody responses, and 3) acceptability of VZV GMT antibody responses
after concomitant vaccination.


Inclusion Criteria:

- History of varicella or residence in a VZV-endemic area for >=30 years

- 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:

- History of hypersensitivity to any vaccine component

- Previously received any varicella or zoster vaccine

- Received an influenza vaccine for the 2015-16 season

- History of Herpes zoster

- Received immunoglobulin, monoclonal antibodies, or any blood products within 5 months
before study vaccination

- Pregnant or breastfeeding

- Known or suspected immune dysfunction

- Experienced Guillain-Barré syndrome within 6 weeks

- Severe thrombocytopenia or any other coagulation disorder
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