VAD00004_PEARL
Research type
Research Study
Full 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)
IRAS ID
1009350
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi Pasteur Inc.
Clinicaltrials.gov Identifier
Research summary
Respiratory syncytial virus (RSV) is a common respiratory virus that causes cold-like symptoms. RSV can cause serious lung illnesses leading to hospitaliszation and possible long term respiratory complications. This study evaluates a live-attenuated experimental vaccine against RSV (called RSVt vaccine) to determine if infants and toddlers who are given the RSVt vaccine are protected from RSV infection and RSV-related disease.
This study is taking place in about 20 countries around the world. It will include about 6300 children (6 to less than 22 months of age). Each child will participate for 2 years. Participants will be assigned by chance, like flipping a coin, to receive either RSVt vaccine or placebo (a dummy vaccine). Both RSVt vaccine and the placebo will be administered in the nose using a nasal spray device.
The RSVt vaccine contains a live weakened form of RSV. The placebo contains the same liquid as the one used in the RSVt vaccine but without the RSV and active ingredients. RSVt vaccine and placebo are given as a nasal spray. Each participant will receive the RSVt vaccine or placebo twice: once on the day they join the study and once about 56 days later. The participants will visit the clinic 3 times for vaccination and/or to give a blood sample. If participants have symptoms of RSV infection, they will also visit the clinic to give a nasal swab sample to test for RSV infection.
Sanofi Pasteur Inc., is the sponsor of this study.REC name
HSC REC A
REC reference
24/NI/0038
Date of REC Opinion
30 May 2024
REC opinion
Further Information Favourable Opinion