Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Model scores of the 29,894 trials active now.
Model score 3% 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 19% of the time (731 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 2012-01-05, after 2010-12-09 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 2012-01-05. 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: timenewchronicbirthdisease
Phrases that lowered it: healthyvaccinevaccinationperiodsubjects -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 4.6% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 452 (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
-
Has a data monitoring committee: not given (lowers risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Sponsor's past trials: 1292 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: double (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
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Maximum age: 0.25 (raises risk) · Who can join
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
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 0.16 (typical: 18)
- Maximum age
- 0.25 (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
- 1292 (typical: 32)
- Sponsor's past termination rate
- 4.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 452 (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
- 73 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 26 (typical: 412.5)
- Drug's FAERS reports marked serious
- 82.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, infectious disease, digestive
- Drugs matched to FDA substances
- pneumococcal vaccine
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
- Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age NCT00970307 · started 2009 · scored riskier than 0% of active trials completed
- Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants NCT01204658 · started 2010 · scored riskier than 2% of active trials completed
- Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants NCT01000974 · started 2010 · scored riskier than 1% of active trials completed
- Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants NCT00871338 · started 2009 · scored riskier than 0% of active trials completed
- Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age. NCT00871741 · started 2009 · scored riskier than 0% of active trials terminated
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.