This study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45
Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.
GSK Investigational Site
East Melbourne, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
Number of Subjects With a Varicella Vaccine Response
Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.
Time frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Time frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Number of Subjects With a Varicella Vaccine Response
Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At 6.5 months post-transplantation = 2 months post first dose of vaccination
Number of Seropositive Subjects for Anti-varicella Antibodies
The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4.
Time frame: At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination)
Anti-varicella Antibody Titers
Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Time frame: At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
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Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
Number of Subjects With Any Fever
Any = fever equal to or greater than (≥) 37.5 °C. Grade 3 fever = fever above (\>) 39.0 °C. Related = fever assessed by the investigator as related to the vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Any and Related Rash
Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related).
Time frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the active phase of the study (up to Month 24)