A Phase III, randomized, double-blind, placebo-controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RSV Maternal vaccine, administered IM to pregnant women 18 to 49 years of age, for prevention of RSV associated LRTI in their infants up to 6 months of age.
Study Period: May 2021- October 2023
Sample Size: 85Doner Name: GlaxoSmithKline Biologicals SA
Project Description:
Background:Respiratory Syncytial Virus (RSV) is a highly contagious human pathogen that causes respiratory tract infections in people of all ages, but young infants below 1 year of age have the highest incidence of severe disease (bronchiolitis, pneumonia), peaking at 1-3 months of age. To date, no licensed vaccine is available for RSV infection.
Objective: The primary objective of this study is to assess the efficacy of a single dose of the RSV Maternal vaccine administered to maternal participants in preventing RSV-associated severe or very severe lower respiratory tract infections (LRTIs) in their infant participants up to 6 months of age.
Method:Randomized, double-blind, placebo controlled multi-country study. A total of 85 pregnant women will be enrolled in Bangladesh Projahnmo Sylhet site.