A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

• Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies [ Time Frame: Baseline and 6 weeks following vaccine administration ] [ Designated as safety issue: No ]
  VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
  
  
• Number of Participants Reporting an Adverse Experience (AE) [ Time Frame: Up to 42 days following vaccine administration ] [ Designated as safety issue: Yes ]

  An AE is defined as any unfavorable and unintended change in the

  structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.

  
  
• Number of Participants Reporting a Serious Adverse Experience (SAE) [ Time Frame: Up to 42 days following vaccine administration ] [ Designated as safety issue: Yes ]
  An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
  
  
• Number of Participants Reporting a Serious Adverse Experience [ Time Frame: Within 5 days after the blood draw at approximately 20 months following vaccine administration ] [ Designated as safety issue: Yes ]
  An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
  
  
• Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) [ Time Frame: Up to 5 days following vaccine administration ] [ Designated as safety issue: Yes ]
  The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
  
  
• Number of Participants Reporting Systemic Adverse Experiences [ Time Frame: Up to 42 days following vaccine administration ] [ Designated as safety issue: Yes ]
  Systemic AEs included all reported AEs except injection-site AEs
  
  
• Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) [ Time Frame: Up to 42 days following vaccine administration ] [ Designated as safety issue: Yes ]
  Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.
  
  

This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.