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This combination refers to the concomitant administration of a routine pediatric 5-in-1 vaccine (targeting diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b) and Sanofi's investigational live-attenuated respiratory syncytial virus (RSV) vaccine, SP0125. The RSV component, also known as RSV/ΔNS2/Δ1313/I1314L, was an intranasal candidate designed for infants and toddlers aged 6 to 24 months. This co-administration was evaluated in the Phase III CORAL study to ensure that the immune response to the routine pediatric vaccines was not compromised by the addition of the RSV vaccine. While the routine components (marketed as Pentacel) are widely approved, Sanofi discontinued the development of the SP0125 RSV vaccine candidate after it failed to meet efficacy endpoints in Phase III clinical trials.
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