Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

NCT01444781 on ClinicalTrials.gov Phase 3 Sanofi Pasteur, a Sanofi Company (industry) Started 2011-09-30 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, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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 2013-10-31, after 2011-09-30 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 2013-10-31. 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: therapycancerchemotherapystageprimary
Phrases that lowered it: vaccinevaccinationhealthyreceipthepatitis
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 3.3% (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 38 (lowers risk) · Sponsor's track record
Sponsor's past trials: 123 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 25% (raises risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Minimum age: 1 (lowers risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Blinding: single (lowers risk) · Design
Maximum age: 2 (lowers risk) · Who can join
Number of arms: 3 (lowers risk) · Design
Keywords listed: 7 (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: single (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 7 (typical: 1)

Who can join

Minimum age: 1 (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: 123 (typical: 32)
Sponsor's past termination rate: 3.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 38 (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: 8 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3 (typical: 412.5)
Drug's FAERS reports marked serious: 87.5% (typical: 85.6%)
Drug's FAERS reports with a death: 25% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, infectious disease, respiratory, digestive
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

Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™ NCT00654901 · started 2008 · scored riskier than 0% of active trials completed
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination NCT01983540 · started 2013 · scored riskier than 0% of active trials completed
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants NCT01177722 · started 2010 · scored riskier than 1% of active trials completed
Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand NCT04429295 · started 2020 · scored riskier than 1% of active trials completed
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants NCT00831753 · started 2008 · 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.