Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Reaches Its Final Stage and Will Soon Begin Statistical Unblinding

2023-10-18 Source:Aimbio
Aimei Vaccine (06660) announced that the Phase III clinical trial of the group's 13-valent pneumococcal polysaccharide conjugate investigational vaccine started recruiting subjects at five sites, including Lincang and Dali in Yunnan in February 2022, with a total of 3780 enrolled subjects. The trial is currently in the phase of blood sample collection six months after full vaccination, with the basic immunogenicity MOPA serum testing completed to date and statistical unblinding set to begin soon.

Previously, the Phase I clinical trial of this vaccine commenced subject enrollment at the Liucheng Disease Control and Prevention Center in Guangxi in February 2021 and concluded the enrollment of all 200 subjects from 2 months to 59 years old in June 2021. As per the obtained trial results thus far, the vaccine has demonstrated good safety and immunogenicity.

This vaccine is intended to prevent diseases caused by the 13 pneumococcal serotypes included in the vaccine (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The group has completed the construction of the production workshop for this vaccine, designed with a capacity of 30 million doses.

According to reports, the 13-valent pneumococcal conjugate vaccine is one of the best-selling vaccine varieties in the world. According to Pfizer's 2022 annual report, the global sales of Pfizer's pneumococcal conjugate vaccine amounted to approximately $6.337 billion in 2022.