A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
Model scores of the 29,894 trials active now.
Model score 4% 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 6% of the time (122 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 2015-08-21, after 2012-10-10 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 2015-08-21. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: heartdiseasesubjectinflammatorytherapy
Phrases that lowered it: vaccinevaccinationparticipantsreceiptparticipant -
Primary purpose: prevention (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers 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: 90 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 909 (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
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Drug's FAERS reports with a death: 12.7% (lowers risk) · Drug's FDA history
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Minimum age: 55 (raises risk) · Who can join
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Number of arms: 6 (lowers risk) · Design
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Blinding: not given (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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- not given (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 55 (typical: 18)
- Maximum age
- 74 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 909 (typical: 32)
- Sponsor's past termination rate
- 4.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 90 (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
- 134 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 42 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- pneumococcal vaccine, pneumococcal valent conjugate 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 & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS NCT00963235 · started 2009 · scored riskier than 5% of active trials completed
- Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults NCT06151288 · started 2023 · scored riskier than 1% of active trials completed
- Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020) NCT03950856 · started 2019 · scored riskier than 2% of active trials completed
- Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults NCT05266456 · started 2022 · scored riskier than 1% of active trials completed
- Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE) NCT03950622 · started 2019 · 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.