Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age

NCT06546423 on ClinicalTrials.gov Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) (government) Started 2024-07-12 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 7% of the time (106 trials).

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

How it ended

Completed on 2025-06-04, after 2024-07-12 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 2025-06-04. 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: transplanttime ofthe timediseasecause
Phrases that lowered it: vaccinereceiptnasalparticipantvaccines
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Primary purpose: prevention (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Collaborators: 3 (lowers risk) · Design
Sponsor's past trials: 1482 (raises risk) · Sponsor's track record
Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 73 (lowers risk) · Sponsor's track record
Minimum age: 2 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 13.7% (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 99.4% (raises risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Number of arms: 3 (lowers 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: 1 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: quadruple (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 3 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 2 (typical: 18)
Maximum age: 4.92 (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: 1482 (typical: 32)
Sponsor's past termination rate: 8.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 73 (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: 161 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3 (typical: 412.5)
Drug's FAERS reports marked serious: 99.4% (typical: 85.6%)
Drug's FAERS reports with a death: 13.7% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: ringer s

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

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children NCT03596801 · started 2018 · scored riskier than 3% of active trials completed
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children NCT03387137 · started 2017 · scored riskier than 3% of active trials completed
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age NCT04520659 · started 2022 · scored riskier than 2% of active trials completed
Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children NCT01254175 · started 2010 · scored riskier than 2% of active trials completed
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers NCT04491877 · started 2020 · scored riskier than 3% 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.