A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)

NCT02114385 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2014-03-24 Completed

Riskier than 1% of active trials

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 6% of the time (876 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 2015-04-22, after 2014-03-24 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 2015-04-22. 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: therapylesionschemotherapymenradiation
Phrases that lowered it: vaccinevaccinationsubjectvaccinesimmunogenicity
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 17.1% (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Sponsor's past trials: 1011 (raises risk) · Sponsor's track record
Blinding: quadruple (lowers risk) · Design
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 137 (lowers risk) · Sponsor's track record
Maximum age: 26 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Disease area, infectious disease: Yes (lowers risk) · Disease area
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Disease area, psychiatry: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 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: 3 (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: 1

Who can join

Minimum age: 16 (typical: 18)
Maximum age: 26 (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: 1011 (typical: 32)
Sponsor's past termination rate: 17.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 137 (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, urogenital
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 Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213) NCT03493542 · started 2018 · scored riskier than 2% of active trials completed
Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017) NCT03546842 · started 2018 · scored riskier than 3% of active trials completed
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) NCT01047345 · started 2010 · scored riskier than 4% of active trials completed
Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America NCT00546078 · started 2008 · scored riskier than 3% of active trials completed
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age NCT05496231 · started 2022 · scored riskier than 2% 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.