Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
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 12% of the time (118 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-12-27, after 2023-02-06 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2024-12-27. 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: interventiontime ofstablemonths ofenrollment
Phrases that lowered it: vaccinevaccinationreceiptparticipantinfluenza -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 3.9% (lowers risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Primary purpose: prevention (lowers risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 22 (lowers risk) · Sponsor's track record
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Minimum age: 0.5 (lowers risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 283 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.5 (typical: 18)
- Maximum age
- 1.92 (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
- 283 (typical: 32)
- Sponsor's past termination rate
- 3.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 22 (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
- 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
- Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers NCT04491877 · started 2020 · scored riskier than 3% of active trials completed
- A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers NCT06705140 · started 2024 · scored riskier than 2% of active trials terminated
- Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers NCT06397768 · started 2024 · scored riskier than 1% of active trials terminated
- Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers NCT06252285 · started 2024 · scored riskier than 1% of active trials terminated
- Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age NCT03916185 · started 2019 · scored riskier than 4% 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.