A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19

NCT04869592 on ClinicalTrials.gov Phase 1/2 National Vaccine and Serum Institute, China (industry) Started 2021-04-25 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, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (118 trials).

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

How it ended

Completed on 2023-08-29, after 2021-04-25 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 2023-08-29. 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: leukemiacellhave receivedfunctionenrollment
Phrases that lowered it: vaccinationvaccinehealthyimmunogenicitysubjects
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 1/2 (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Collaborators: 3 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Number of arms: 15 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: double (raises risk) · Design

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: 1/2 (typical: 2)
Number of arms: 15 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 3 (typical: 0)
Keywords listed: 1

Who can join

Minimum age: 3 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 1 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 3 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: sars cov2

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 GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above NCT05408312 · started 2022 · 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
Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Vaccine Booster NCT05897190 · started 2022 · scored riskier than 0% of active trials completed
Phase II Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) NCT05770180 · started 2023 · scored riskier than 1% of active trials completed
Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 vs Aged 18 Years Old and Above NCT04917523 · started 2021 · 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.