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NCT06151288 (VAX-31 in invasive pneumococcal disease): BVCT ex-ante prediction vs. reported outcome

On 12 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 3 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT06151288
Drug Name
VAX-31
Drug MoA
31-valent pneumococcal conjugate antigen-based vaccine
Drug Modality
vaccine
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
invasive pneumococcal disease (IPD)
Human Patients
1015
Sponsor
Vaxcyte
Phase
Phase 1 Phase 2

Prediction of , index 1598

Prospective Prediction
Prediction Index
1598
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit non-inferior-and-non-superior-to PCV20)
Technical Prediction
SUCCESS (statistically significant clinical benefit non-inferior-and-non-superior-to PCV20)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
114 days in advance
Readout Data Interpretation
OPA response non-inferiority criteria met for all 20 serotypes against SoC PCV20 and regulatory immunogenicity met for all 31 serotypes.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Active-Controlled, Parallel-Group, Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Healthy Adults Aged 50 Years and Older
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
1015
Lead sponsor
Vaxcyte, Inc.
Conditions
Pneumococcal Vaccines
Interventions
BIOLOGICAL: 31 valent pneumococcal conjugate vaccine; BIOLOGICAL: 20 valent pneumococcal conjugate vaccine
Design
Randomized · Parallel · Quadruple
Primary purpose
Prevention
Start
2023-11-08
Primary completion
2024-07-17
Completion
2024-07-17
Results first posted
2025-07-28
Primary outcomes
  • Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group (7 days after vaccination)
  • Percentage of Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group Vaccination in Each Age Group (7 days after vaccination)
  • Percentage of Subjects Reporting Unsolicited Adverse Event in Each Age Group (1 month after vaccination)
  • Percentage of Subjects Reporting Serious Adverse Event (6 months after vaccination)
  • Percentage of Subjects Reporting New Onset of Chronic Illness (6 months after vaccination)

NCT06151288 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials