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Study Design
Definitions
Tab Number 3
Tab Number 4
Tab Number 5
A Phase 3, multicentre, randomized, double-blind, placebo-controlled global study.
Adapted from the ABRYSVO Product Monograph.1
The study objective was the assessment of vaccine efficacy defined as the RRR in the ABRYSVO group vs. placebo for infant participants born to maternal participants receiving one dose of ABRYSVO.
The following two primary efficacy endpoints were assessed in parallel within
90/120/150/180 days after birth:
RSV-positive LRTI and severe RSV-positive LRTI were both defined as a medically attended visit with RT-PCR confirmed RSV illness with the following criteria:
Check out the MATISSE trial for more information.
RRR: relative risk reduction; RSV: respiratory syncytial virus; MA: medically attended; LRTD: lower respiratory tract disease; RT-PCR: reverse transcription-polymerase chain reaction
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