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NCT01158157 · ClinicalTrials.gov registry record · Phase 3

VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

A Phase 3 study of Smallpox Vaccine Adverse Reaction, sponsored by Emergent BioSolutions.

Completed
Registry status
Phase 3
Development phase
25
Enrollment target
1
Study location

NCT01158157: Completed Phase 3 study of Smallpox Vaccine Adverse Reaction, sponsored by Emergent BioSolutions.

NCT01158157 is a Phase 3 study of Smallpox Vaccine Adverse Reaction that has completed, run by Emergent BioSolutions. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01158157, a Phase 3 study of Smallpox Vaccine Adverse Reaction, has completed, sponsored by Emergent BioSolutions.

COMPLETED
Registry status
Phase 3
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).

Interventions

  • BIOLOGICAL ACAM2000

Study Locations (1)

Florida

  • Cangene Plasma Resources, Mid-Florida - Altamonte Springs

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2010-09-13
Est. Completion 2012-02-14
Phase Phase 3
Emergent BioSolutions

34 total trials

What the finished NCT01158157 record still lists

NCT01158157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Smallpox Vaccine Adverse Reaction appearing as the primary indexed condition, and to 1 intervention - of which ACAM2000 is the first listed.

NCT01158157 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT01158157 about?

NCT01158157 is a clinical study titled "VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV". The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).

What is the current status of trial NCT01158157?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2010-09-13. Estimated completion is 2012-02-14.

What conditions does trial NCT01158157 study?

This clinical trial studies the following conditions: Smallpox Vaccine Adverse Reaction.

What interventions are being tested in trial NCT01158157?

The interventions under investigation include: ACAM2000 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01158157?

This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01158157 being conducted?

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

How this trial's enrollment target compares

Where NCT01158157's enrollment target sits among peer trials

25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01158157, the US trial registry maintained by the National Library of Medicine. NCT01158157 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.