A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)

NCT03565900 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2018-09-12 Completed

Riskier than 19% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 2% 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 (876 trials).

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

How it ended

Completed on 2021-11-04, after 2018-09-12 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 2021-11-04. 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

Sponsor's past termination rate: 17.4% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: allogeneiccelltransplantstemleukemia
Phrases that lowered it: vaccinevaccinationimmunogenicityparticipantparticipants
Accepts healthy volunteers: No (raises risk) · Who can join
Primary purpose: prevention (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Blinding: triple (raises risk) · Design
Sponsor's past trials: 1227 (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 78 (lowers risk) · Sponsor's track record
Minimum age: 3 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 71.8% (lowers risk) · Drug's FDA history
Design: parallel (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: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: triple (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: 3 (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: 1227 (typical: 32)
Sponsor's past termination rate: 17.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 78 (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: 517 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 104 (typical: 412.5)
Drug's FAERS reports marked serious: 71.8% (typical: 85.6%)
Drug's FAERS reports with a death: 7.9% (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

Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients NCT00980655 · started 2010 · scored riskier than 22% of active trials completed
A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant NCT01903928 · started 2013 · scored riskier than 47% of active trials completed
Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant NCT02396134 · started 2015 · scored riskier than 98% of active trials completed
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant NCT01588015 · started 2012 · scored riskier than 81% of active trials completed
Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT) NCT01379209 · started 2011 · scored riskier than 75% 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.