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NCT05477524 (PF-07307405 in Lyme Disease): BVCT ex-ante prediction vs. reported outcome

On 10 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 23 Mar 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically partially significant and commercially sufficient.

Clinical Trial

NCTID
NCT05477524
Acronym
VALOR
Drug Name
PF-07307405 (LB6V)
Drug MoA
multivalent OspA recombinant vaccine VLA15
Drug Modality
vaccine
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Lyme Disease
Human Patients
12546
Sponsor
Pfizer Inc / Valneva SE
Phase
Phase 3

Prediction of , index 1588

Prospective Prediction
Prediction Index
1588
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in infection risk reduction)
Technical Prediction
SUCCESS (statistically significant clinical benefit in infection risk reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
682 days in advance
Readout Data Interpretation
VLA15 achieved statistically significant placebo-adjusted 74.8% efficacy from 1 day post-dose 4 (95% CI 21.7, 93.9); vaccine well tolerated
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially 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 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6-VALENT OSPA-BASED LYME DISEASE VACCINE IN HEALTHY PARTICIPANTS ≥5 YEARS OF AGE
Phase
Phase 3
Status
Completed
Enrollment
12546
Lead sponsor
Pfizer
Conditions
Lyme Disease
Interventions
BIOLOGICAL: VLA15; OTHER: Saline
Design
Randomized · Parallel · Quadruple
Primary purpose
Prevention
Start
2022-08-04
Primary completion
2026-01-07
Completion
2026-01-07
Primary outcomes
  • Relative incidence rate reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group (Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)).)
  • Percentage of participants reporting local reactions (Within 7 days following each study intervention administration)
  • Percentage of participants reporting systemic events (Within 7 days following each study intervention administration)
  • Percentage of participants reporting adverse events (AEs) (Through 1 month following each study intervention administration)
  • Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) (Through study completion, up to approximately 42 months.)

NCT05477524 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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