Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Study Overview: Sanofi is conducting a Phase 4 clinical study titled ‘A Phase 4, Open-label, Single-arm Clinical Study to Describe Safety and Efficacy Outcomes Associated With the Use of Nirsevimab in Neonates and Infants Born During or Entering Their First Respiratory Syncytial Virus (RSV) Season and in Children up to 24 Months of Age Who Remain Vulnerable to Severe RSV Disease Through Their Second RSV Season.’ The study aims to evaluate the safety and efficacy of nirsevimab in preventing severe RSV disease in young children in India, a significant step in combating RSV-related health issues.
Intervention/Treatment: The study tests the monoclonal antibody nirsevimab, administered as an intramuscular injection. It is designed to prevent severe RSV disease in neonates, infants, and young children up to 24 months of age.
Study Design: This is an interventional study with a single-group assignment. There is no masking involved, and the primary purpose is prevention. Participants receive either one or two intramuscular injections of nirsevimab, depending on their age and RSV season exposure.
Study Timeline: The study began on July 31, 2025, with its primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on August 14, 2025, indicating the study is actively recruiting participants.
Market Implications: This study could positively impact Sanofi’s stock performance by reinforcing its position in the pediatric RSV prevention market. Successful outcomes may enhance investor confidence and position Sanofi favorably against competitors in the RSV immunization space.
The study is ongoing, with further details available on the ClinicalTrials portal.