Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age

NCT01978093 on ClinicalTrials.gov Phase 3 GlaxoSmithKline (industry) Started 2014-02-01 Completed

Riskier than 2% of active trials

Model scores of the 29,894 trials active now.

Model score 3% 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 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 2016-03-18, after 2014-02-01 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 2016-03-18. 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: typeallowedpriorprotocolterm
Phrases that lowered it: vaccinehealthyvaccinationimmunogenicitysubjects
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 5.4% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 316 (raises risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Design: parallel (raises risk) · Design
Sponsor's past trials: 1905 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Keywords listed: 6 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 11.4% (lowers risk) · Drug's FDA history
Primary purpose: prevention (lowers risk) · Design
Maximum age: 0.23 (raises risk) · Who can join
Disease area, infectious disease: Yes (lowers risk) · Disease area
Disease area, psychiatry: No (lowers risk) · Disease area
Minimum age: 0.12 (raises risk) · Who can join
Responsible party: sponsor (lowers risk) · Design

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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 6 (typical: 1)

Who can join

Minimum age: 0.12 (typical: 18)
Maximum age: 0.23 (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: 1905 (typical: 32)
Sponsor's past termination rate: 5.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 316 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 166 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 31 (typical: 412.5)
Drug's FAERS reports marked serious: 86.7% (typical: 85.6%)
Drug's FAERS reports with a death: 11.4% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: haemophilus influenzae type b, neisseria meningitidis, 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

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants NCT01000974 · started 2010 · scored riskier than 1% of active trials completed
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines NCT01144663 · started 2010 · scored riskier than 1% of active trials completed
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014 NCT00614614 · started 2008 · scored riskier than 3% of active trials completed
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants NCT01204658 · started 2010 · scored riskier than 2% of active trials completed
Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants NCT00871338 · started 2009 · scored riskier than 0% 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.