Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

NCT00841763 on ClinicalTrials.gov Phase 3 Novartis (industry) Started 2008-10-31 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 6% of the time (876 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 2009-11-30, after 2008-10-31 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 2009-11-30. 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: chroniccancertherapydiseasechemotherapy
Phrases that lowered it: vaccineinfluenzavaccinationreceiptimmunogenicity
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 3.9% (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 186 (lowers risk) · Sponsor's track record
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: 23.8% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Sponsor's past trials: 333 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises 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.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (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: 333 (typical: 32)
Sponsor's past termination rate: 3.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 186 (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: 42 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8 (typical: 412.5)
Drug's FAERS reports marked serious: 92.9% (typical: 85.6%)
Drug's FAERS reports with a death: 23.8% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease
Drugs matched to FDA substances: 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

Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects NCT00841646 · started 2008 · scored riskier than 0% of active trials completed
Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects Using Four Different Vaccination Schedules NCT00848029 · started 2008 · scored riskier than 0% of active trials completed
Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects NCT01651104 · started 2012 · scored riskier than 1% of active trials completed
Immunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04 NCT00814385 · started 2008 · scored riskier than 0% of active trials completed
A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age NCT06087640 · started 2023 · 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.