Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

NCT03826719 on ClinicalTrials.gov Phase 1/2 SK Chemicals Co., Ltd. (industry) Started 2014-02-17 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, 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 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 2014-03-28, after 2014-02-17 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 2014-03-28. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: iiacutesafety tolerabilitypriorrandomized double
Phrases that lowered it: vaccinevaccinationinfluenzaimmunogenicityhealthy
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 4.3% (lowers risk) · Sponsor's track record
Phase: 1/2 (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Design: parallel (raises risk) · Design
Minimum age: 19 (lowers risk) · Who can join
Primary purpose: prevention (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 59 (lowers risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 10 (lowers risk) · Sponsor's track record
Disease area, infectious disease: Yes (lowers risk) · Disease area
Disease area, psychiatry: No (lowers risk) · Disease area
Sponsor's past trials: 23 (lowers risk) · Sponsor's track record

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: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: quadruple (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: 19 (typical: 18)
Maximum age: 59 (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: 23 (typical: 32)
Sponsor's past termination rate: 4.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 10 (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: 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, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults NCT03893669 · started 2012 · scored riskier than 0% of active trials completed
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects NCT02344134 · started 2013 · scored riskier than 0% of active trials completed
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults NCT01612000 · started 2012 · scored riskier than 1% of active trials completed
Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older NCT02464163 · started 2015 · scored riskier than 0% of active trials completed
Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months NCT03704740 · started 2018 · scored riskier than 1% 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.