Pediatric Immunization Clinical Trials & Studies

Respiratory syncytial virus (RSV) is a common viral infection in infants and toddlers, with nearly all children experiencing it by the age of two. It is the most common cause of lower respiratory tract infections (LRTIs) in infants. RSV disease is typically mild, but it can lead to more severe disease, especially in infants and toddlers. It is also a leading cause of hospitalization in infants worldwide.^1–4

Fortunately, babies can be protected against RSV disease through immunizations developed through clinical trials. RSV protection can be offered for babies via maternal immunization (RSV vaccine administered to pregnant persons) or with RSV antibodies given directly to the baby.¹

Children may respond differently to vaccines and immunizations that have been tested and approved for adults, which is why it is important to specifically test them in these populations. As children are vulnerable populations who require extra precautions in clinical trials, they have historically been disproportionately excluded from vaccine and immunization trials, resulting in a lack of safety and effectiveness data for these individuals.^5-7

Learn more about diversity in Sanofi’s clinical trials.

Here at Sanofi, to ensure that clinical trials are conducted safely, we adhere to the guidance of regulatory bodies that have outlined special considerations for conducting clinical trials involving pregnant people and children.

Sanofi’s clinical trials are held to the highest best practice standards, including but not limited to Good Research Practices (GRP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and ICH E6 Good Clinical Practice. Learn more about our Bioethics in Clinical Trials Framework.