Valneva Reports Completion of VLA1553 in P-III (VLA1553-301) Trial for the Treatment of Chikungunya
Shots:
- The company has completed the P-III (VLA1553-301) trial to evaluate VLA1553 (IM) vs PBO in 4115 adults aged ≥18yrs. with Chikungunya at 44 sites in the US. The pre-submission process with the US FDA is expected in Q2’22
- The trial met all 1EPs & 2EPs i.e., 98.9% of patients achieved protective levels of CHIKV neutralizing Abs @1mos. & 96.3% @6mos. after receiving a single vaccination & the immunogenicity profile was maintained over time @6mos.
- Additionally, the safety profile was consistent with previous results in all age groups & was well tolerated in 3082 patients evaluated for safety. VLA1553 has received BTD & FTD from the US FDA along with EMA’s PRIME designations for the same indication
Ref: Globe Newswire | Image: Boursier
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