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NCT00485134 · ClinicalTrials.gov registry record · Phase 1

Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection

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

Completed
Registry status
Phase 1
Development phase
113
Enrollment target

NCT00485134 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 113 participants.

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The verdict

NCT00485134, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.

COMPLETED
Registry status
Phase 1
Development phase
113 participants
Enrollment target

Study Summary

The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.

Interventions

  • BIOLOGICAL 240 µg Shigella flexneri 2a Invaplex 50 vaccine
  • BIOLOGICAL 480 µg Shigella flexneri 2a Invaplex 50 vaccine
  • BIOLOGICAL 690 Shigella flexneri 2a Invaplex 50 vaccine
  • OTHER Shigella challenge strain

Trial Details

FieldValue
Enrollment Target 113 participants
Start Date 2007-05
Est. Completion 2010-09
Phase Phase 1

What the Registry Record Tells You About NCT00485134

The ClinicalTrials.gov registry entry for NCT00485134 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is U.S. Army Medical Research and Development Command, which has 77 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which 240 µg Shigella flexneri 2a Invaplex 50 vaccine is the first listed.

NCT00485134 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00485134 about?

NCT00485134 is a clinical study titled "Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection". The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.

What is the current status of trial NCT00485134?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 113 participants. The study started on 2007-05. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00485134?

The interventions under investigation include: 240 µg Shigella flexneri 2a Invaplex 50 vaccine (BIOLOGICAL), 480 µg Shigella flexneri 2a Invaplex 50 vaccine (BIOLOGICAL), 690 Shigella flexneri 2a Invaplex 50 vaccine (BIOLOGICAL), Shigella challenge strain (OTHER).

Who is sponsoring clinical trial NCT00485134?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.