Vaxcyte VAX-31 meets all primary endpoints in Phase 3 trial
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- Vaxcyte announced that its pneumococcal vaccine candidate met all primary immunogenicity endpoints.
- The pivotal Phase 3 trial evaluated immune responses across 31 target serotypes in adult populations.
- The company stated it plans to submit a license application in the first half of 2028.
Vaxcyte (NASDAQ:PCVX) reported that VAX-31 met all prespecified primary endpoints in its OPUS-1 Phase 3 trial.
In adults aged 50 and older, all 28 shared serotypes met noninferiority criteria compared to existing vaccines.
The clinical results showed that 3 unique serotypes and 1 cross-reactive serotype met noninferiority and superiority criteria.
All 321 safety and immune comparisons in adults aged 18 to 49 met noninferiority thresholds against older demographics.
Vaxcyte stated that it expects additional clinical trial results from OPUS-2 and OPUS-3 in the first half of 2027.
The company stated that these combined trial results are expected to support a planned license application in 2028.
