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NCT05540522 (Quadrivalent modRNA vaccine in Influenza): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 28 May 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05540522
Drug Name
Quadrivalent modRNA vaccine
Drug MoA
Quadrivalent anti-hemagglutinin mRNA vaccine
Drug Modality
Vaccine
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Influenza
Human Patients
45789
Sponsor
Pfizer
Phase
Phase 3

Prediction of , index 1419

Prospective Prediction
Prediction Index
1419
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate clinical benefit with non-inferior-to-SoC anti-ILI efficacy for A/H3N2 for >=65 ysd participants) partial FAILURE (commercially insufficient clinical benefit with inferior-to-adjuvanted SoC anti-ILI efficacy for B/Victoria; B/Yamagata; and A/H1N1 for >=65 ysd participants)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit for A/H3N2 for >=65 ysd participants) partial FAILURE (statistically insignificant clinical benefit for B/Victoria; B/Yamagata; and A/H1N1 for >=65 ysd participants)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
499 days in advance
Readout Data Interpretation
qIRV failed to achieve non-inferiority in anti-ILI efficacy compared with SoC licensed QIV for people >= 65 years
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA COMPARED TO LICENSED INACTIVATED INFLUENZA VACCINE IN HEALTHY ADULTS 18 YEARS OF AGE OR OLDER
Phase
Phase 3
Status
Completed
Enrollment
45789
Lead sponsor
Pfizer
Conditions
Influenza, Human
Interventions
BIOLOGICAL: Quadrivalent influenza modRNA vaccine; BIOLOGICAL: Quadrivalent influenza vaccine
Design
Randomized · Parallel · Quadruple
Primary purpose
Prevention
Start
2022-09-12
Primary completion
2024-03-12
Completion
2024-03-12
Results first posted
2025-05-08
Primary outcomes
  • Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years (Day 15 to surveillance cut-off (approximately 6 months))
  • Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years (Day 15 up to primary surveillance cut-off (approximately 1 year))
  • Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years (From Day 1 to Day 7 after study vaccination)
  • Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years (From Day 1 to Day 7 after study vaccination)
  • Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years (From Day 1 to Day 7 after study vaccination)

NCT05540522 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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