A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age

NCT05630846 on ClinicalTrials.gov Phase 2 GlaxoSmithKline (industry) Started 2022-12-14 Completed

Riskier than 3% of active trials

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% 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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-10-14, after 2022-12-14 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 2024-10-14. 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: concurrentinvasiveriskpriorperformance
Phrases that lowered it: vaccinehealthyparticipantparticipantsvaccination
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Phase: 2 (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Sponsor's past trials: 2720 (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Blinding: double (raises risk) · Design
Sponsor's past termination rate: 7.2% (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Number of arms: 4 (lowers risk) · Design
Minimum age: 4 (lowers 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: 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: 4 (typical: 1)

Who can join

Minimum age: 4 (typical: 18)
Maximum age: 6 (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: 2720 (typical: 32)
Sponsor's past termination rate: 7.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 100 (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
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 on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age NCT05084508 · started 2022 · scored riskier than 3% of active trials completed
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age NCT02184572 · started 2014 · scored riskier than 2% of active trials completed
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age NCT01621802 · started 2012 · scored riskier than 3% of active trials completed
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
Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months NCT06399003 · started 2024 · scored riskier than 1% 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.