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COMPLETED Phase 1

Invaplex 50 Vaccine Dose-Ranging

NCT00082069 · View on ClinicalTrials.gov ↗

Study Summary

The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits.

Conditions Studied

Interventions

  • BIOLOGICAL Shigella flexneri 2a Invaplex 50

Study Locations (1)

Maryland

  • Walter Reed Army Institute of Research — Silver Spring

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2004-04
Est. Completion 2006-11
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00082069

The ClinicalTrials.gov registry entry for NCT00082069 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 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 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diarrhea appearing as the primary indexed condition, and to 1 intervention — of which Shigella flexneri 2a Invaplex 50 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00082069 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00082069 about?

NCT00082069 is a clinical study titled "Invaplex 50 Vaccine Dose-Ranging". The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up vi...

What is the current status of trial NCT00082069?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2004-04. Estimated completion is 2006-11.

What conditions does trial NCT00082069 study?

This clinical trial studies the following conditions: Diarrhea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00082069?

The interventions under investigation include: Shigella flexneri 2a Invaplex 50 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00082069?

This trial is sponsored by U.S. Army Medical Research and Development Command, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00082069 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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