The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

NCT01513551 on ClinicalTrials.gov Phase 2 Merck Sharp & Dohme LLC (industry) Started 2012-03-13 Completed

Riskier than 2% 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 8% of the time (780 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 2013-02-15, after 2012-03-13 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 2013-02-15. 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: therapyin subjectsdiseaseof studyevidence
Phrases that lowered it: vaccinereceipthealthyvaccinationblood
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 16.6% (raises risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 163 (lowers risk) · Sponsor's track record
Sponsor's past trials: 870 (raises risk) · Sponsor's track record
Blinding: triple (raises risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 12.6% (lowers risk) · Drug's FDA history
Number of arms: 3 (lowers risk) · Design
Disease area, psychiatry: No (lowers risk) · Disease area
Maximum age: not given (raises risk) · Who can join

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: 2
Number of arms: 3 (typical: 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: 1

Who can join

Minimum age: 50 (typical: 18)
Maximum age: not given (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: 870 (typical: 32)
Sponsor's past termination rate: 16.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 163 (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: 119 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 35 (typical: 412.5)
Drug's FAERS reports marked serious: 83.2% (typical: 85.6%)
Drug's FAERS reports with a death: 12.6% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: pneumococcal conjugate vaccine, pneumococcal 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

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) NCT05569954 · started 2022 · scored riskier than 4% of active trials completed
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4) NCT05464420 · started 2022 · scored riskier than 4% of active trials completed
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults NCT03828617 · started 2019 · scored riskier than 2% of active trials completed
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3) NCT05425732 · started 2022 · scored riskier than 3% of active trials completed
A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults NCT06182124 · started 2023 · scored riskier than 4% 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.