Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

NCT01449812 on ClinicalTrials.gov Phase 3 GlaxoSmithKline (industry) Started 2011-10-01 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 2012-01-16, after 2011-10-01 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 2012-01-16. 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: hoursprimarytime ofdiseaseprior
Phrases that lowered it: healthyvaccinevaccinationsubjectsevaluate the
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Primary purpose: prevention (lowers risk) · Design
Sponsor's past termination rate: 4.7% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 429 (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor's past trials: 1483 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
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
Maximum age: 2 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Disease area, psychiatry: No (lowers risk) · Disease area
Blinding: none (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: 3 (typical: 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: 2 (typical: 1)

Who can join

Minimum age: 1.5 (typical: 18)
Maximum age: 2 (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: 1483 (typical: 32)
Sponsor's past termination rate: 4.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 429 (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: pentetic acid

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' Infanrix/Hib in Children NCT00696423 · started 2008 · scored riskier than 3% of active trials completed
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose NCT01171989 · started 2010 · scored riskier than 2% of active trials completed
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) NCT01453998 · started 2011 · scored riskier than 3% of active trials completed
Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers NCT01106092 · started 2010 · scored riskier than 1% of active trials completed
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia NCT02858440 · started 2016 · 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.