A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)
Model scores of the 29,894 trials active now.
Model score 3% 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 8% of the time (780 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 2012-07-31, after 2010-10-14 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 2012-07-31. 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: cancersclerosisof studydiseaseprior
Phrases that lowered it: vaccinehealthyvaccinationparticipantreceipt -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 16.2% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Sponsor's past trials: 722 (raises risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Maximum age: 0.23 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 211 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 11.1% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 0.12 (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 77.8% (lowers risk) · Drug's FDA history
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Number of arms: 3 (lowers 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
- Number of arms
- 3 (typical: 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
- 3 (typical: 1)
Who can join
- Minimum age
- 0.12 (typical: 18)
- Maximum age
- 0.23 (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
- 722 (typical: 32)
- Sponsor's past termination rate
- 16.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 211 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 108 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 41 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- aluminum, 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
- Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) NCT01215175 · started 2009 · scored riskier than 0% of active trials completed
- Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants NCT04398706 · started 2020 · scored riskier than 1% of active trials completed
- Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024) NCT03885934 · started 2019 · scored riskier than 2% of active trials completed
- Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026) NCT04016714 · started 2019 · scored riskier than 2% of active trials completed
- Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years. NCT04583618 · started 2020 · scored riskier than 3% 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.