A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age
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 5% of the time (4,470 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 2016-04-30, after 2014-11-30 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 2016-04-30. 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: serumrecurrentdefined asmonthstime
Phrases that lowered it: vaccinehealthyvaccinationinfluenzaadministration -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Number of arms: 5 (lowers risk) · Design
-
Blinding: triple (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
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Disease area, psychiatry: No (lowers risk) · Disease area
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Responsible party: sponsor (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
- 1 (typical: 2)
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- triple (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
- 2 (typical: 18)
- Maximum age
- 6 (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
- 13 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- none of the 14 tracked areas
- 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
- A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age NCT05900154 · started 2023 · scored riskier than 3% of active trials completed
- Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine NCT01290419 · started 2010 · scored riskier than 1% of active trials completed
- A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants NCT02927873 · started 2017 · scored riskier than 3% of active trials completed
- RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly NCT01709019 · started 2012 · scored riskier than 2% of active trials completed
- 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
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.