Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.

ABSTRACT:

Background

Respiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants.

Methods

Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vaccine or placebo. Infants were followed for 180 days to assess outcomes related to lower respiratory tract infection and for 364 days to assess safety. The primary end point was RSV-associated, medically significant lower respiratory tract infection up to 90 days of life, and the primary analysis of

SUBMITTER: Madhi SA 

PROVIDER: S-EPMC7299433 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature