diphtheria + tetanus + pertussis + poliomyelitis + haemophilus influenzae type b + hepatitis b vaccine + respiratory syncytial virus vaccine

This drug entry refers to the concomitant administration of Sanofi Pasteur's investigational live-attenuated respiratory syncytial virus (RSV) vaccine, SP0125 (also known as RSVt or RSV/ΔNS2/Δ1313/I1314L), alongside routine pediatric hexavalent vaccines. SP0125 is an intranasally administered vaccine designed for infants and toddlers aged 6 to 24 months, utilizing specific genetic deletions (ΔNS2, Δ1313) and a stabilizing mutation (I1314L) to ensure attenuation and temperature sensitivity. The hexavalent component, such as Vaxelis, is administered intramuscularly and provides protection against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and hepatitis B. This combination was evaluated in the Phase III CORAL trial to assess the non-interference of concomitant administration on the antibody responses of the individual components. Although the hexavalent vaccines are standard approved pediatric products, Sanofi discontinued the development of the SP0125 RSV vaccine candidate after it failed to meet efficacy endpoints in Phase III studies.

Brand names

PentacelRecombivax HB

Other names

Investigational live-attenuated RSV vaccineHexavalent pediatric vaccine