A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)

NCT04640402 on ClinicalTrials.gov Phase 2 Jiangsu Province Centers for Disease Control and Prevention (academic or other) Started 2020-11-17 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 2% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2021-11-23, after 2020-11-17 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2021-11-23. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cellspatientsdiseasebrainchronic
Phrases that lowered it: vaccinehealthyvaccinationimmunogenicitysingle
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Number of arms: 16 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Blinding: triple (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 1.5% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 7 (lowers risk) · Sponsor's track record
Maximum age: 85 (raises risk) · Who can join

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 2
Number of arms: 16 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 85 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 43 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 7 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 263 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 178 (typical: 412.5)
Drug's FAERS reports marked serious: 86.3% (typical: 85.6%)
Drug's FAERS reports with a death: 1.5% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: covid19 vaccine

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) (WSK-V102) NCT05765604 · started 2023 · scored riskier than 0% of active trials completed
Phase I Trial of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell) NCT04530656 · started 2020 · scored riskier than 0% of active trials completed
Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above NCT05381350 · started 2022 · scored riskier than 0% of active trials completed
A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine NCT05652543 · started 2023 · scored riskier than 3% of active trials completed
Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine NCT05433285 · started 2022 · scored riskier than 0% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.