Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

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 10% of the time (1,463 trials).

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

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-09-09. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: months of12 monthsmajorseizuresecond
  Phrases that lowered it: vaccinehealthyimmunogenicityparticipantssingle dose
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Sponsor's past termination rate: 15.6% (raises risk) · Sponsor's track record
• Primary purpose: prevention (lowers risk) · Design
• Sponsor's past trials: 1959 (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 170 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 0.21 (lowers 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.

• A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants NCT04645966 · started 2020 · scored riskier than 4% of active trials terminated
• Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants NCT02106390 · started 2014 · scored riskier than 1% of active trials completed
• Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants NCT03621670 · started 2018 · scored riskier than 2% of active trials completed
• A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years NCT01339923 · started 2011 · scored riskier than 1% of active trials completed
• Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants NCT00806195 · 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.