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passages: document
passages: A double-blind , randomized , controlled , multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax . The vaccine Zostavax has been shown to prevent herpes zoster ( HZ ) and postherpetic neuralgia and is recommended for individuals > or =60 years of age . This study compared the safety and the immunogenicity of a refrigerator-stable formulation ( Zostavax refrigerated ) with those of the current formulation ( Zostavax frozen ) in subjects > or =50 years of age . Subjects with a negative history for HZ were randomized 1:1 to receive one dose of either formulation . Enrollment was stratified 1:2 by age ( 50 to 59 years and > or =60 years ) . Safety was evaluated for 28 days postvaccination . Varicella-zoster virus ( VZV ) antibody responses were measured by a glycoprotein enzyme-linked immunosorbent assay ( gpELISA ) . The primary endpoints were the VZV antibody geometric mean titer ( GMT ; day 28 ) , the VZV antibody geometric mean rise ( GMR ; days 1 to 28 ) , and the incidence of vaccine-related serious adverse experiences ( AEs ) over 28 days . The refrigerated ( n = 182 ) and frozen ( n = 185 ) formulations induced similar GMTs ( 727.4 and 834.4 gpELISA units/ml , respectively ) ; the estimated GMT ratio ( refrigerated formulation/frozen formulation ) was 0.87 ( 95 % confidence interval , 0.71 to 1.07 ) . The GMRs were 2.6- and 2.9-fold , respectively . No vaccine-related serious AEs were reported in either group , and the safety profiles of the formulations were generally similar . The frequencies of injection-site AEs during follow-up were 35.6 % and 46.4 % in the refrigerated and the frozen formulation groups , respectively , and were generally mild . The frequencies of systemic AEs were similar in the two groups , and those of vaccine-related AEs were approximately 6 % in both groups . The refrigerator-stable formulation of Zostavax has an acceptable safety profile and is as immunogenic as the frozen formulation ; thus , the vaccine may be used in clinical settings where freezer availability is limited .
entities: 1253
entities: Intervention_Pharmacological
entities: Zostavax .
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entities: Intervention_Pharmacological
entities: Zostavax
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entities: Intervention_Pharmacological
entities: Zostavax
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entities: Intervention_Pharmacological
entities: Zostavax
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entities: Intervention_Pharmacological
entities: Zostavax
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entities: Outcome_Other
entities: safety
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entities: Outcome_Physical
entities: immunogenicity
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entities: Outcome_Other
entities: Safety
entities: 1261
entities: Outcome_Physical
entities: Varicella-zoster virus ( VZV ) antibody responses
entities: 1262
entities: Outcome_Physical
entities: VZV antibody geometric mean titer ( GMT
entities: 1263
entities: Outcome_Physical
entities: VZV antibody geometric mean rise ( GMR
entities: 1264
entities: Outcome_Adverse-effects
entities: incidence of vaccine-related serious adverse experiences ( AEs )
entities: 1265
entities: Outcome_Physical
entities: GMTs
entities: 1266
entities: Outcome_Physical
entities: GMT
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entities: Outcome_Physical
entities: GMRs
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entities: Outcome_Adverse-effects
entities: vaccine-related serious AEs
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entities: Outcome_Other
entities: safety
entities: 1270
entities: Outcome_Adverse-effects
entities: injection-site AEs
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entities: Outcome_Adverse-effects
entities: systemic AEs
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entities: Outcome_Adverse-effects
entities: vaccine-related AEs
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entities: Outcome_Other
entities: safety
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entities: Outcome_Physical
entities: immunogenic
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entities: Participant_Age
entities: subjects > or =50 years of age .
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entities: Participant_Condition
entities: Subjects with a negative history for HZ
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entities: Participant_Age
entities: Enrollment was stratified 1:2 by age ( 50 to 59 years and > or =60 years )