A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants

NCT05242432 on ClinicalTrials.gov Phase 3 Janssen Pharmaceutical K.K. (industry) Started 2022-04-01 Terminated

Riskier than 14% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 10% of the time (1,463 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2023-03-20, after 2022-04-01 start.

Reason given by the sponsor: “business”

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 2023-03-20. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 20 (lowers risk) · Who can join
Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Primary purpose: prevention (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: chronicacutediseasemajorcopd
Phrases that lowered it: participantparticipantsvaccineevaluatevaccination
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Number of arms: 4 (lowers risk) · Design
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 100 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Blinding: double (raises 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: 3 (typical: 2)
Number of arms: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 100 (typical: 32)
Sponsor's past termination rate: 5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 16 (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 Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older NCT04354480 · started 2020 · scored riskier than 9% of active trials completed
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older NCT04908683 · started 2021 · scored riskier than 4% of active trials completed
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older NCT03982199 · started 2019 · scored riskier than 7% of active trials terminated
A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older NCT05071313 · started 2021 · scored riskier than 9% of active trials completed
A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health NCT03339713 · started 2017 · 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.