Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)

NCT04481191 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2020-08-25 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 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

Completed on 2021-05-08, after 2020-08-25 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 2021-05-08. 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: lymphomachemotherapyleukemiatransplantationmyeloma
Phrases that lowered it: vaccinehealthyimmunogenicityvaccinationvaccines
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 17.2% (raises risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Sponsor's past trials: 1293 (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 128 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Minimum age: 0.13 (lowers risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 0.13 (typical: 18)
Maximum age: 0.17 (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: 1293 (typical: 32)
Sponsor's past termination rate: 17.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 128 (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

Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024) NCT02062385 · started 2014 · scored riskier than 2% of active trials completed
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Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers NCT06397768 · started 2024 · scored riskier than 1% of active trials terminated
Phase III Study of Liquid Formulation of ROTAVIN NCT03703336 · started 2019 · scored riskier than 1% of active trials completed
Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine NCT04344054 · started 2021 · 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.