Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines

NCT05925127 on ClinicalTrials.gov Phase 2/3 Novavax (industry) Started 2023-10-16 Completed

Riskier than 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 13% of the time (47 trials).

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

How it ended

Completed on 2024-05-21, after 2023-10-16 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 2024-05-21. 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: carcinomatherapycancerprioradjuvant
Phrases that lowered it: vaccinevaccinationparticipantsparticipantvaccines
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 3.1% (lowers risk) · Sponsor's track record
Design: crossover (lowers risk) · Design
Primary purpose: prevention (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Phase: 2/3 (raises risk) · Design
Number of arms: 7 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 99 (lowers risk) · Who can join
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Minimum age: 50 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
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: 2/3 (typical: 2)
Number of arms: 7 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: prevention (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 50 (typical: 18)
Maximum age: 99 (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: 32
Sponsor's past termination rate: 3.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 8 (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: 8 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2 (typical: 412.5)
Drug's FAERS reports marked serious: 87.5% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: nvx cov2373

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

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Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines NCT05372588 · started 2022 · scored riskier than 0% of active trials completed
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine NCT04961541 · started 2021 · scored riskier than 1% of active trials completed
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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.