BioinvestGPT ApS · Research use only

NCT05823974 (Flu mRNA in Influenza): BVCT ex-ante prediction vs. reported outcome

On 27 Feb 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 4 Apr 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant against placebo yet commercially insufficient (especially for influenza B as we accurately predicted).

Clinical Trial

Drug Name
Flu mRNA
Drug MoA
Multivalent anti-hemagglutinin mRNA vaccine
Drug Modality
mRNA medicine
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Influenza
Human Patients
1256
Sponsor
GSK / CureVac
Phase
Phase 1 Phase 2

Prediction of , index 1486

Prospective Prediction
Prediction Index
1486
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate clinical benefit with non-inferior-to-FDQ21A-NH anti-ILI efficacy for A/H3N2 for >=65 ysd participants); partial FAILURE (commercially insufficient clinical benefit with inferior-to-FDQ21A-NH 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
37 days in advance
Readout Data Interpretation
numerically higher geometric mean titers for influenza A in both young and elderly age groups and lower geometric mean titers for influenza B in both young and elderly age groups.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant against placebo yet commercially insufficient (especially for influenza B as we accurately predicted)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
1275
Lead sponsor
GlaxoSmithKline
Conditions
Influenza, Human
Interventions
BIOLOGICAL: F2C22C/DL001Z; BIOLOGICAL: F2B22A/DL001Z; BIOLOGICAL: F2B22B/DL001Z; BIOLOGICAL: F2B22C/DL001Z; BIOLOGICAL: F2B22D/DL001Z; BIOLOGICAL: F2B22E/DL001Z; BIOLOGICAL: F2F22A/DL001Z; BIOLOGICAL: F2F22B/DL001Z; BIOLOGICAL: F2F22C/DL001Z; BIOLOGICAL: F2F22D/DL001Z; BIOLOGICAL: F2F22E/DL001Z; COMBINATION_PRODUCT: Control 1; BIOLOGICAL: F2F23D/DL001Z-NH; BIOLOGICAL: F2F23A/DL001Z-NH; BIOLOGICAL: F2F23B/DL001Z-NH; COMBINATION_PRODUCT: Control 2; BIOLOGICAL: F2F23C/DL001Z-NH; COMBINATION_PRODUCT: Control 3; BIOLOGICAL: F2F22F/DL001Z
Design
Randomized · Parallel · Quadruple
Primary purpose
Prevention
Start
2023-04-27
Primary completion
2024-07-02
Completion
2024-12-18
Results first posted
2025-07-23
Primary outcomes
  • Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) (Day 1 to Day 7)
  • Number of Participants Reporting Any Solicited Systemic AEs (Day 1 to Day 7)
  • Number of Participants Reporting Any Unsolicited AEs (Day 1 to Day 28)
  • Number of Participants Reporting Serious Adverse Events (SAEs) (Day 1 to Day 183)
  • Number of Participants Reporting AEs of Special Interest (AESIs) (Day 1 to Day 183)

NCT05823974 on ClinicalTrials.gov

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