CanSino Biologics Inc. a leading China-based vaccines specialist (HKG: 6185), has announced the initiation of a Phase III clinical study for its DTcP vaccine, targeting infants and young children under 2 years old. This development is accompanied by the enrollment of the first subjects in the trial.
Quality Consistency and Market Potential
The DTcP vaccine, a component pertussis vaccine, is designed to ensure quality consistency across batches, which translates to a more stable product quality. Notably, there is no domestically produced similar product currently available in the Chinese market, highlighting the potential for CanSino’s DTcP vaccine to fill a significant gap.
Positive Phase I Results and Study Design
The Phase I study of the product demonstrated good safety, with no level 3 adverse reactions and no serious adverse events (SAE) related to the vaccine. Building on the data from Phase I, the Phase III study is designed to assess the safety and immunogenicity of the DTcP vaccine in infants aged 2 and 3 months old. The study will be conducted in a randomized, blinded, and positive controlled manner to ensure rigorous evaluation of the vaccine’s efficacy and safety profile.-Fineline Info & Tech
