Sanofi SA ((SNY)), Sanofi ((SNYNF)), Sanofi ((DE:SNW)) announced an update on their ongoing clinical study.
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Sanofi is conducting a Phase 3 clinical study titled A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers. The study aims to evaluate the safety and immune response of the investigational PCV21 vaccine compared to the licensed 15vPCV (Vaxneuvance) in infants starting from approximately 2 months of age. This research is significant as it could lead to broader protection against pneumococcal diseases in young children.
The study tests two interventions: the experimental PCV21 vaccine and the active comparator 15vPCV. Both vaccines are administered intramuscularly, aiming to boost immunity against pneumococcal infections when given alongside routine pediatric vaccines.
This interventional study is randomized and follows a parallel assignment model. It employs a modified double-blind approach, where participants, caregivers, and certain study staff are unaware of the group assignments, while those administering the vaccines are informed. The primary goal is prevention.
The study began on May 22, 2025, with a primary completion date anticipated in the future. The most recent update was submitted on August 19, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
The outcome of this study could significantly impact Sanofi’s market position, potentially boosting its stock if the PCV21 vaccine proves effective. Positive results could enhance investor confidence and position Sanofi competitively against other vaccine manufacturers.
The study is currently recruiting, and further details can be accessed on the ClinicalTrials portal.