VAD00004 / PEARL
Title:
Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)
Acronym:
VAD00004 / PEARL
Timeline:
2023 – 2025
Status:
Ongoing
Funder:
SANOFI
Objective
The primary objective of the VAD00004 study is to demonstrate the clinical efficacy of the RSVt vaccine for the prevention of reverse transcriptase-polymerase chain reaction (RT-PCR) confirmed RSV lower respiratory tract disease (LRTD) after 2 doses in infants and toddlers aged 6 months to <22 months.