A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults

NCT06382311 on ClinicalTrials.gov Phase 1/2 GlaxoSmithKline (industry) Started 2024-04-18 Completed

Riskier than 2% of active trials

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 12% of the time (118 trials).

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

How it ended

Completed on 2026-01-13, after 2024-04-18 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 2026-01-13. 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: stabletherapycellallowedcarcinoma
Phrases that lowered it: healthyvaccineinfluenzaimmunogenicityvaccination
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Phase: 1/2 (raises risk) · Design
Primary purpose: prevention (lowers risk) · Design
Sponsor's past trials: 2775 (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 82 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 5.8% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 78.8% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Disease area, respiratory: Yes (raises risk) · Disease area
Sponsor's past termination rate: 7.5% (lowers risk) · Sponsor's track record
Design: sequential (lowers risk) · Design
Maximum age: 85 (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: 1/2 (typical: 2)
Number of arms: 27 (typical: 2)
Allocation: randomized
Design: sequential (typical: 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: 8 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 85 (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: 2775 (typical: 32)
Sponsor's past termination rate: 7.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 82 (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: 8791 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 929 (typical: 412.5)
Drug's FAERS reports marked serious: 78.8% (typical: 85.6%)
Drug's FAERS reports with a death: 5.8% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, respiratory
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

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A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults NCT05446740 · started 2022 · scored riskier than 2% of active trials completed
A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above NCT07204964 · started 2025 · scored riskier than 2% of active trials completed
Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above NCT05829356 · started 2023 · 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.