Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers
Model scores of the 29,894 trials active now.
Model score 6% 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 4% of the time (217 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-08-10, after 2015-07-21 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 2016-08-10. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectmonthspriorcellseffective
Phrases that lowered it: participantshealthyasthmaparticipantrespiratory -
Primary purpose: other (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 5.8% (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 96 (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 1046 (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 3 (lowers risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1046 (typical: 32)
- Sponsor's past termination rate
- 5.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 96 (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, respiratory
- 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
- Challenge Infection of Healthy Adult Volunteers With RSV A2 NCT03388645 · started 2018 · scored riskier than 3% of active trials completed
- Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers NCT03624790 · started 2018 · scored riskier than 1% of active trials completed
- Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults NCT04785612 · started 2020 · scored riskier than 2% of active trials completed
- Mucosal and Systemic Immunity After Viral Challenge of Healthy Volunteers Vaccinated With Inactivated Influenza Vaccine Via the Intranasal Versus Intramuscular Route NCT03845231 · started 2019 · scored riskier than 20% of active trials completed
- Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model NCT03180801 · started 2016 · 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.