BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05566639 (mRNA-1010 in influenza): BVCT ex-ante prediction vs. reported outcome

On 19 Feb 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 20 Dec 2024 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
NCT05566639
Drug Name
mRNA-1010
Drug MoA
LNP-mediated mRNA influenza vaccine
Drug Modality
mRNA medicine
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
influenza
Human Patients
22502
Sponsor
Moderna
Phase
Phase 3

Prediction of , index 887

Prospective Prediction
Prediction Index
887
Prediction Date
Commercial Prediction
FAILURE (inferior anti-ILI efficacy for influenza A)
Technical Prediction
FAILURE (statistically insignificant)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
670 days in advance
Readout Data Interpretation
mRNA-1010 failed to achieve non-inferiority in anti-ILI efficacy compared with the SoC active control arm Fluarix quadrivalent (p=0.1715 CI -24.1% to 22.2% with non-inferiority margin = 10%)
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-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older
Phase
Phase 3
Status
Completed
Enrollment
22502
Lead sponsor
ModernaTX, Inc.
Conditions
Seasonal Influenza
Interventions
BIOLOGICAL: mRNA-1010; BIOLOGICAL: Fluarix Quadrivalent
Design
Randomized · Parallel · Triple
Primary purpose
Prevention
Start
2022-09-14
Primary completion
2024-01-05
Completion
2024-01-05
Results first posted
2025-01-16
Primary outcomes
  • Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (7 days post-vaccination)
  • Number of Participants With Unsolicited Adverse Events (AEs) (Up to 28 days post-vaccination)
  • Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation (Day 1 through Day 361 (Month 12))
  • Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine (14 days post-vaccination through Day 181 (Month 6))

NCT05566639 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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