Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)
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 6% of the time (776 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 2009-07-31, after 2008-07-31 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 2009-07-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cellserumradiationgreaterstage
Phrases that lowered it: vaccinevaccinationinfluenzahealthyblood -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Responsible party: not given (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 45 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 6 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: 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 (typical: 2)
- Number of arms
- 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
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (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
- 5 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- H5N1 (Clade 2) Vaccination of Adults and Elderly NCT00680069 · started 2008 · scored riskier than 1% of active trials completed
- Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine NCT01244867 · started 2010 · scored riskier than 1% of active trials completed
- Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents NCT01052402 · started 2009 · scored riskier than 0% of active trials completed
- Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults NCT00895544 · started 2009 · scored riskier than 0% of active trials completed
- H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers NCT01657929 · started 2012 · 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.