Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women
Model scores of the 29,894 trials active now.
Model score 3% 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 (122 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 2013-05-31, 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 2013-05-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectplacebomoderateheartor equal
Phrases that lowered it: vaccineinfluenzavaccinationreceiptvaccines -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 96 (lowers risk) · Sponsor's track record
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Blinding: triple (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 16.7% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: government (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 49 (lowers risk) · Who can join
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Sponsor's past trials: 861 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 49 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 861 (typical: 32)
- Sponsor's past termination rate
- 4.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 96 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 96 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- cold, influenza virus 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
- Novartis H1N1 Vaccine in Pregnant Women NCT00992719 · started 2009 · scored riskier than 2% of active trials completed
- 2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women NCT01173211 · started 2010 · scored riskier than 3% of active trials completed
- H1N1 Vaccine in Pregnant Women NCT00963430 · started 2009 · scored riskier than 1% of active trials completed
- Sanofi H1N1 + TIV - Adults and Elderly NCT00943878 · started 2009 · scored riskier than 0% of active trials completed
- Sanofi Pasteur, TIV + H1N1, Pediatric Population NCT00943202 · 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.