A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine

NCT02692170 on ClinicalTrials.gov Phase 1/2 Aribio Lab Co., Ltd. (industry) Started 2012-12-07 Completed

Riskier than 7% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 16% of the time (257 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2015-05-28, after 2012-12-07 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2015-05-28. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Minimum age: 20 (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subject hassubject isheartpatientventricular
Phrases that lowered it: to evaluatevaccineclinicalrandomizedsingle
Phase: 1/2 (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Design: parallel (raises risk) · Design
Number of arms: 5 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Blinding: double (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Maximum age: 50 (lowers risk) · Who can join
Collaborators: 0 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Disease area, psychiatry: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history

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: 5 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 50 (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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (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: none of the 14 tracked areas
Drugs matched to FDA substances: none matched

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

Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children NCT04188223 · started 2019 · scored riskier than 0% of active trials completed
A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002 NCT06162299 · started 2024 · scored riskier than 4% of active trials terminated
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine NCT02117934 · started 2014 · scored riskier than 7% of active trials completed
A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate NCT05727267 · started 2024 · scored riskier than 2% of active trials completed
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine NCT01005407 · started 2010 · scored riskier than 2% 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.