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NCT02445963 · ClinicalTrials.gov registry record · Phase 1

Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)

A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target

NCT02445963: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.

NCT02445963 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02445963, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target

Study Summary

This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).

Primary Outcome

Number of adverse events related to the vaccine for each arm

Interventions

  • BIOLOGICAL Shigella flexneri 2a InvaplexAR

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2015-10-01
Est. Completion 2016-05-13
Phase Phase 1

What the finished NCT02445963 record still lists

NCT02445963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 1 intervention - of which Shigella flexneri 2a InvaplexAR is the first listed.

NCT02445963 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02445963 about?

NCT02445963 is a clinical study titled "Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)". This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).

What is the current status of trial NCT02445963?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2015-10-01. Estimated completion is 2016-05-13.

What interventions are being tested in trial NCT02445963?

The interventions under investigation include: Shigella flexneri 2a InvaplexAR (BIOLOGICAL).

Who is sponsoring clinical trial NCT02445963?

This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02445963's enrollment target sits among peer trials

38 1197th of 2000 higher than 797 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 NCT02445963, the US trial registry maintained by the National Library of Medicine. NCT02445963 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.