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NCT01653392 · ClinicalTrials.gov registry record

BioThrax® (Anthrax) Vaccine in Pregnancy Registry

A clinical trial, sponsored by Emergent BioSolutions.

Completed
Registry status
98
Enrollment target

NCT01653392: Completed study, sponsored by Emergent BioSolutions.

NCT01653392 is a clinical trial that has completed, run by Emergent BioSolutions. The registered enrollment target is 98 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01653392 has completed, sponsored by Emergent BioSolutions.

COMPLETED
Registry status
98 participants
Enrollment target

Study Summary

The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.

Primary Outcome

Pregnancy outcomes measured include live birth, still birth, spontaneous abortion, elective termination, ectopic pregnancy, or molar pregnancy Note: Twin or higher order multiple pregnancies may have more than one outcome.

Interventions

  • BIOLOGICAL Observational Intervention

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2012-07
Est. Completion 2020-02
Emergent BioSolutions

34 total trials

What the finished NCT01653392 record still lists

NCT01653392 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 98 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Observational Intervention is the first listed.

NCT01653392 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01653392 about?

NCT01653392 is a clinical study titled "BioThrax® (Anthrax) Vaccine in Pregnancy Registry". The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.

What is the current status of trial NCT01653392?

This trial is currently completed. The enrollment target is 98 participants. The study started on 2012-07. Estimated completion is 2020-02.

What interventions are being tested in trial NCT01653392?

The interventions under investigation include: Observational Intervention (BIOLOGICAL).

Who is sponsoring clinical trial NCT01653392?

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

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Source: ClinicalTrials.gov NCT01653392, the US trial registry maintained by the National Library of Medicine. NCT01653392 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.