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NCT03518125 · ClinicalTrials.gov registry record · Phase 2

BARDA Securing Anthrax Immunity For the Elderly

A Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.

Completed
Registry status
Phase 2
Development phase
305
Enrollment target

NCT03518125: Completed Phase 2 study, sponsored by Biomedical Advanced Research and Development Authority.

NCT03518125 is a Phase 2 study that has completed, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 305 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03518125, a Phase 2 study, has completed, sponsored by Biomedical Advanced Research and Development Authority.

COMPLETED
Registry status
Phase 2
Development phase
305 participants
Enrollment target

Study Summary

This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.

Primary Outcome

Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.

Interventions

  • BIOLOGICAL AV7909
  • BIOLOGICAL BioThrax
  • DRUG Sodium chloride injection USP, 0.9% (placebo)

Trial Details

FieldValue
Enrollment Target 305 participants
Start Date 2018-05-09
Est. Completion 2019-12-09
Phase Phase 2

What the finished NCT03518125 record still lists

NCT03518125 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher).

The record links to 0 conditions, and to 3 interventions - of which AV7909 is the first listed.

NCT03518125 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03518125 about?

NCT03518125 is a clinical study titled "BARDA Securing Anthrax Immunity For the Elderly". This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.

What is the current status of trial NCT03518125?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 305 participants. The study started on 2018-05-09. Estimated completion is 2019-12-09.

What interventions are being tested in trial NCT03518125?

The interventions under investigation include: AV7909 (BIOLOGICAL), BioThrax (BIOLOGICAL), Sodium chloride injection USP, 0.9% (placebo) (DRUG).

Who is sponsoring clinical trial NCT03518125?

This trial is sponsored by Biomedical Advanced Research and Development Authority, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03518125's enrollment target sits among peer trials

305 166th of 2000 higher than 1,835 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03518125, the US trial registry maintained by the National Library of Medicine. NCT03518125 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.