Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults

NCT00853255 on ClinicalTrials.gov Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) (government) Started 2010-07-31 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, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 4% of the time (217 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 2011-12-31, after 2010-07-31 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 2011-12-31. 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: priorworklungstopeffective
Phrases that lowered it: vaccinevaccinationinfluenzahealthyvaccines
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 3.8% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Primary purpose: prevention (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 97 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Design: single group (raises risk) · Design
Sponsor's past trials: 806 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Maximum age: 49 (lowers risk) · Who can join
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Sponsor type: government (raises risk) · Sponsor's track record
Disease area, infectious disease: Yes (lowers risk) · Disease area

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: 1 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: prevention (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: 49 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: government (typical: academic or other)
Sponsor's past trials: 806 (typical: 32)
Sponsor's past termination rate: 3.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 97 (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: 7 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
Drugs matched to FDA substances: chicken

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

Safety and Immunogenicity of Live Influenza A Vaccine for Avian Influenza H7N7 NCT00922259 · started 2010 · scored riskier than 0% of active trials completed
Evaluating the Safety and Immune Response of an H7N7 Vaccine in Healthy Adults NCT01534468 · started 2012 · scored riskier than 0% of active trials completed
Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals NCT02151344 · started 2014 · scored riskier than 0% of active trials completed
A Study to Evaluate the Safety and Immunogenicity of H7N9 Influenza Vaccine (AT-501) in Healthy Adult Subjects NCT02436928 · started 2015 · scored riskier than 2% of active trials completed
Safety and Immunogenicity of a Live Attenuated H7N9 Influenza Virus Vaccine in Healthy Adults NCT01995695 · started 2013 · 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.