The P-III (STRIDE-10) trial assessed the immunogenicity, tolerability and safety of V116 vs PPSV23 in adults (n=1,484, 50yrs. & above) not receiving pneumococcal vaccine before
The study depicted non-inferior immune responses with V116 for the 12 shared serotypes with PPSV23, superior immune responses for the 9 serotypes unique to V116 & superior immune responses for 8/9 serotypes unique to V116 as evaluated by the proportions of patients with ≥4-fold rise
Furthermore, V116’s review by the US FDA & the EMA is currently underway. The drug also received the US FDA’s priority review with the decision anticipated in Jun 2024
Ref: Merck | Image: Merck
Related News:- Merck Highlights Results from Various P-III Trials of V116 Vaccine for Pneumococcal Diseases at ISPPD-13 2024
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