Complete Announced during: Premarket · announced Mon 8:01a ET (premarket); before = Fri close; first trade Mon 8:02a ET; time = SEC 8-K acceptance
Vaxcyte (Nasdaq: PCVX) reported topline results from a Phase 3 trial of VAX-31 in pneumococcal disease on October 5, 2026. The company said the trial met its primary endpoint. ClinicalTrials.gov lists 4049 enrolled participants (NCT07284654).
Trial details
- Drug
- VAX-31Type Biological Route intramuscular
- Treats
- Studied as a treatment for pneumococcal disease.Condition Pneumococcal Disease
- Patients
- 4,049 patients (actual enrollment)5 arms · 30 sites in 1 country
- Phase
- Phase 3
- Design
- Randomized, quadruple-blind, parallel-group
- Primary endpoint
- Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above (1 month after vaccination) Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site) (up to 7 days after vaccination) Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain) (up to 7 days after vaccination)
- Key secondary endpoints
- Serotype-specific IgG geometric mean concentrations (GMC) in 50 year olds and above
- Serotype-specific IgG GMC in 18 to 49 year olds and 50 to 64 year olds
- Result
- Met endpoint
- Safety
- In the study, VAX-31 was well tolerated and demonstrated a safety profile similar to PCV20 and PCV21 at all ages studied.
- Sponsor
- Vaxcyte Nasdaq: PCVX
- Dates
- Study start Dec 1, 2025Primary completion Sep 17, 2026Announced Oct 5, 2026, 8:01 AM ET (SEC 8-K filing time)
- Trial ID
- NCT07284654 ClinicalTrials.gov
About this trial
This randomized, quadruple-blind, parallel-group Phase 3 trial (NCT07284654) tested VAX-31 in Pneumococcal Disease. Studied as a treatment for pneumococcal disease. It enrolled 4,049 patients across 5 arms at 30 sites in 1 country. The primary endpoint was Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above (1 month after vaccination) Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site) (up to 7 days after vaccination) Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain) (up to 7 days after vaccination). Vaxcyte reported that the trial met its primary endpoint. The study started on Dec 1, 2025 and reached primary completion on Sep 17, 2026.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT07284654
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