Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants

NCT02728869 on ClinicalTrials.gov Phase 1/2 MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. (industry) Started 2016-06-30 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, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (257 trials).

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

How it ended

Completed on 2017-04-30, after 2016-06-30 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 2017-04-30. 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: chemotherapyfailurefunctionmothermarrow
Phrases that lowered it: vaccinehealthyvaccinationimmunogenicityreceipt
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Phase: 1/2 (raises risk) · Design
Drug's FAERS reports with a death: 45.5% (raises risk) · Drug's FDA history
Number of arms: 4 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Blinding: single (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 0.12 (lowers risk) · Who can join
Design: parallel (raises risk) · Design
Maximum age: 45 (lowers risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 11 (lowers risk) · Drug's FDA history
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history

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: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: single (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 0.12 (typical: 18)
Maximum age: 45 (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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (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: 11 (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: 45.5% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: rotavirus 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 Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates NCT03462108 · started 2018 · scored riskier than 0% of active trials completed
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants NCT02141204 · started 2019 · scored riskier than 1% of active trials completed
Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks NCT02914184 · started 2016 · scored riskier than 2% of active trials completed
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine NCT03207750 · started 2017 · scored riskier than 1% of active trials completed
Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine NCT04344054 · started 2021 · scored riskier than 2% 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.