A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011 AM3)

• The number of HZ cases per 1000 person-years of follow-up [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
• The number of participants experiencing serious adverse events [ Time Frame: From vaccination day 1 through 28 days post vaccination dose 4 ] [ Designated as safety issue: Yes ]

• The number of HZ cases per 1000 person-years of follow-up in the STM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
• The number of HZ cases per 1000 person-years of follow-up in the HM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
• Incidence of moderate to severe HZ-associated pain [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: No ]
  Moderate to severe HZ-associated pain is defined as 2 or more occurrences of a score of 3 or greater (0 to 10 scale) on the Zoster Brief Pain Inventory (ZBPI)
• Incidence of HZ complications [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  HZ complications defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.
• Incidence of postherpetic neuralgia (PHN) [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: No ]
  Postherpetic neuralgia (PHN) is defined as a worst pain score (in the last 24 hours) of 3 or greater (0 to 10 scale) on the Zoster Brief Pain Inventory (ZBPI) that persists or appears >= 90 days after the onset of the HZ rash.

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) or hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM, as compared to placebo.

• Biological: V212
  V212 viral antigen for HZ, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
  Other Name: Inactivated Varicella-Zoster (VZV) vaccine
• Biological: Placebo
  Vaccine stabilizer for V212 with no virus antigen, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.

• Experimental: V212 Arm
  0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.
  Intervention: Biological: V212
• Placebo Comparator: Placebo Arm
  0.5 mL SC injection per dose, in a four dose regimen.
  Intervention: Biological: Placebo

Inclusion criteria;

• Participant has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and:
• Participant is ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen
• Participant is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not
• Participant has a life expectancy ≥ 12 months.
• Participant has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.

Exclusion criteria:

• Participant has a history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
• Participant has a prior history of HZ within 1 year of enrollment.
• Participant has received or is expected to receive any varicella or non-study zoster vaccine.
• Participant is currently receiving or expected to receive long-term antiviral prophylaxis (>4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV)
• Participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
• Participant has had any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days post vaccination dose 4
• Participant has had inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.