Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

NCT03673462 on ClinicalTrials.gov Phase 3 Sanofi Pasteur, a Sanofi Company (industry) Started 2018-09-17 Completed

Riskier than 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 6% of the time (876 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2023-03-16, after 2018-09-17 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 2023-03-16. 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: therapyleukemiachemotherapycancerhigh
Phrases that lowered it: vaccinehealthyvaccinationinfluenzareceipt
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 2.1% (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 8.7% (lowers risk) · Drug's FDA history
Minimum age: 0.12 (lowers risk) · Who can join
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
Maximum age: 0.24 (lowers risk) · Who can join
Sponsor's past trials: 235 (lowers risk) · Sponsor's track record
Blinding: quadruple (lowers risk) · Design
Drug's FAERS reports marked serious: 72.3% (lowers risk) · Drug's FDA history

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: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 0.12 (typical: 18)
Maximum age: 0.24 (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: 235 (typical: 32)
Sponsor's past termination rate: 2.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 15 (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: 528 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 104 (typical: 412.5)
Drug's FAERS reports marked serious: 72.3% (typical: 85.6%)
Drug's FAERS reports with a death: 8.7% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: pneumococcal vaccine, pneumococcal valent conjugate vaccine, rotavirus 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 Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers NCT03691610 · started 2018 · scored riskier than 1% of active trials completed
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom NCT03632720 · started 2018 · scored riskier than 2% of active trials completed
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe NCT03547271 · started 2018 · scored riskier than 1% of active trials completed
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US NCT03537508 · started 2018 · scored riskier than 1% of active trials completed
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents NCT02199691 · started 2014 · 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.