Respiratory Syncytial Virus Infections Clinical Trial
Official title:
A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants
The purpose of this study is to determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.
This is a randomized, observer-blind, placebo-controlled trial enrolling third-trimester
pregnant women in the Northern and Southern hemispheres, for up to four consecutive RSV
seasons in each hemisphere. The trial will enroll 4636 third-trimester pregnant subjects.
Women in the third trimester of a singleton uncomplicated pregnancy and 18 to 40 years of age
(inclusive) will be enrolled and randomized in a 1:1 ratio into one of two treatment groups,
active or placebo, over approximately the three months prior to peak RSV season. After the
first global season of enrollment, the randomization scheme will be changed to a 2:1
(active/placebo) ratio to enable more efficient accrual of the safety database.
All maternal subjects will receive a single intramuscular (IM) injection on Day 0 with the
assigned test article, the RSV F vaccine or placebo. Study participation for maternal
subjects will span approximately nine (9) months from the first dose, ending six (6) months
post-delivery. Study follow-up for infant subjects who are consented will span approximately
one (1) year post-delivery.
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