The primary objective of this study is to assess the immune response to an influenza vaccine in adults with B-cell malignancies who are currently receiving treatment with idelalisib in a Gilead-sponsored study (parent study).
Study Type
OBSERVATIONAL
Enrollment
2
Administered per standard of care using a vaccine licensed and recommended in the site's country
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika
Prague, Czechia
Hospital Universitario Ramon y Cajal
Madrid, Spain
Seroconversion Rate: Proportion of Participants with Either a Pre-Vaccination Hemagglutination Inhibition (HI) Titer < 1:10 and a Post-Vaccination HI titer ≥ 1:40, or a Pre-Vaccination HI titer ≥ 1:10 and a ≥ 4-fold Increase in Post-Vaccination HI Titer
Time frame: 28 days [± 7 days] post-vaccination
Seroprotection Rate: Proportion of Participants with HI titer ≥ 1:40 Post-Vaccination
Time frame: 28 days [± 7 days] post-vaccination
Geometric Mean Titers (GMTs) of Antibodies: Pre- and Post-Vaccination GMTs of HI Antibodies Evaluated Prior to and 28 days (± 7 Days) After Vaccination
Time frame: Prior to and 28 days (± 7 days) after vaccination
Percentage of Participants with Adverse Events or Serious Adverse Events From Time of Baseline Blood Draw Until Day 28 (Post Vaccination) Visit
Time frame: Baseline Blood Draw; Day 28 (± 7 days)
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