Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
This study was conducted to obtain safety and immunogenicity data after a booster dose of
 Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was
 compared to similar information obtained after Zoster Vaccine, Live administration to
 age-matched and younger participants who received their first dose of Zoster Vaccine, Live.
 The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in
 participants ≥70 years of age induces an antibody response that is noninferior to that of a
 first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose
 of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus
 (VZV) antibodies.
All participants were followed for one year after completion of the 42-day post-vaccination
 period while Groups 1 and 2 were followed for a total of three years.
Inclusion Criteria:

 -  All Groups:

 -  Must not have a fever of ≥100.4° F on the day of vaccination

 -  Any underlying chronic illness must be in stable condition

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

 -  Group 1:

 -  70 years of age or older

 -  Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and
 received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in
 this study

 -  Group 2:

 -  70 years of age or older

 -  Group 3:

 -  60 to 69 years of age

 -  Group 4:

 -  50 to 59 years of age

 Exclusion Criteria:

 -  All Groups:

 -  History of hypersensitivity reaction to any vaccine component or an
 anaphylactic/anaphylactoid reaction to neomycin

 -  Prior history of herpes zoster

 -  Pregnant or breast-feeding, or expecting to conceive within the duration of the
 study

 -  Has been treated with immunoglobulin or any blood products, other than autologous
 (self-donated) blood transfusion, in the 5 months prior to vaccination

 -  Received any other vaccine within 4 weeks prevaccination

 -  On immunosuppressive therapy

 -  Has known or suspected immune dysfunction

 -  Is taking any non-topical antiviral therapy with activity against herpesviruses,
 including, but not limited to acyclovir, famciclovir, valacyclovir, and
 ganciclovir.

 -  Groups 2, 3, and 4:

 -  Has previously received any varicella or zoster vaccine