Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

NCT00861744 on ClinicalTrials.gov Phase 2 GlaxoSmithKline (industry) Started 2009-06-03 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 2% 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 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 2012-06-18, after 2009-06-03 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 2012-06-18. 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: iichronicsubject haslifefollow up
Phrases that lowered it: vaccinevaccinationhealthyimmunogenicityand safety
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 4.1% (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Phase: 2 (raises risk) · Design
Blinding: triple (raises risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 461 (raises risk) · Sponsor's track record
Sponsor's past trials: 973 (raises risk) · Sponsor's track record
Number of arms: 4 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 1.25 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 80% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Disease area, infectious disease: Yes (lowers risk) · Disease area
Minimum age: 1 (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: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: triple (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 7 (typical: 1)

Who can join

Minimum age: 1 (typical: 18)
Maximum age: 1.25 (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: 973 (typical: 32)
Sponsor's past termination rate: 4.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 461 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 5 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2 (typical: 412.5)
Drug's FAERS reports marked serious: 80% (typical: 85.6%)
Drug's FAERS reports with a death: 20% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: pneumococcal 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

Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older NCT02058563 · started 2014 · scored riskier than 2% 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
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 NCT00751348 · started 2008 · scored riskier than 2% of active trials completed
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life NCT01681992 · started 2012 · scored riskier than 3% 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.