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BioThrax® (Anthrax) Vaccine in Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT01653392
Recruitment Status : Recruiting
First Posted : July 31, 2012
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Pregnancy Complications Pregnancy Outcome Congenital Abnormalities Biological: Observational Intervention

Detailed Description:

This study will use a convenience sample and passive referral to enroll participants.

For the maternal outcome portion of the study, pregnant active duty women who consent to join the registry are expected to complete several surveys over the course of their pregnancy, including an initial enrollment survey, a follow-up survey at or after the 20th week of pregnancy, and a post-delivery survey at two weeks after their delivery due date (unless a pregnancy loss is reported in the 20 week survey).

Outcomes among infants born to women enrolled in the Registry whose pregnancies result in a livebirth will be assessed with a survey during the post-delivery contact, again at 4 months of age, with a final follow-up when the infant reaches one year of age.


Study Design

Study Type : Observational
Estimated Enrollment : 580 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: BioThrax® (Anthrax) Vaccine in Pregnancy Registry
Study Start Date : July 2012
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anthrax
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Anthrax Vaccine Adsorbed
Active duty women who received one or more doses of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period, and all live born infants born to women who join the registry.
Biological: Observational Intervention
This is an observational study, therefore no interventions are specified.


Outcome Measures

Primary Outcome Measures :
  1. Pregnancy Outcomes [ Time Frame: Up to 44 weeks ]
    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.

  2. Maternal Outcomes [ Time Frame: Up to 44 weeks ]
    Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.

  3. Infant Outcomes [ Time Frame: Up to 1 year of age ]
    Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Active duty female service members who received one or more doses of BioThrax® while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period (LMP) All live born infants born to women who join the registry.
Criteria

Inclusion Criteria:

  • Female active duty service member
  • Received one or more dose of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period.

Exclusion Criteria:

  • Non-service member, non-active duty pregnant female.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653392


Contacts
Contact: Susan Farrish 619-553-9255 NHRC-VaccineRegistry@mail.mil

Locations
United States, California
Naval Health Research Center Recruiting
San Diego, California, United States, 92106
Sponsors and Collaborators
Emergent BioSolutions
Naval Health Research Center
Investigators
Principal Investigator: Susan Farrish Naval Health Research Center
More Information

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01653392     History of Changes
Other Study ID Numbers: EBS.AVA.010 / NHRC.2012.0003
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Emergent BioSolutions:
Maternal Mortality
Obstetric Labor, Premature
Eclampsia
Pre-Eclampsia
Abortion, Spontaneous
Diabetes, Gestational
Pregnancy, Ectopic
Hydatidiform Mole
Fetal death
Live birth
Still birth
Premature Birth
Sex ratio
Birth weight

Additional relevant MeSH terms:
Pregnancy Complications
Anthrax
Congenital Abnormalities
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs