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NCT01435811 · ClinicalTrials.gov registry record · Phase 1

Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)

A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT01435811: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01435811 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01435811, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

The purpose of this study is to determine a suitable dose of the human norovirus GII.4 challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals.

Primary Outcome

To determine a suitable dose of the human norovirus GII.4 challenge pool (CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals.

Interventions

  • BIOLOGICAL Norovirus challenge pool (GII.4, CIN-1)

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-08
Est. Completion 2012-11
Phase Phase 1

What the finished NCT01435811 record still lists

NCT01435811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Norovirus challenge pool (GII.4, CIN-1) is the first listed.

NCT01435811 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01435811 about?

NCT01435811 is a clinical study titled "Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)". The purpose of this study is to determine a suitable dose of the human norovirus GII.4 challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals.

What is the current status of trial NCT01435811?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-08. Estimated completion is 2012-11.

What interventions are being tested in trial NCT01435811?

The interventions under investigation include: Norovirus challenge pool (GII.4, CIN-1) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01435811?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01435811's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01435811, the US trial registry maintained by the National Library of Medicine. NCT01435811 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.