BioThrax® (Anthrax) Vaccine in Pregnancy Registry
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ClinicalTrials.gov Identifier: NCT01653392 |
Recruitment Status
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Recruiting
First Posted
: July 31, 2012
Last Update Posted
: February 5, 2018
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Condition or disease | Intervention/treatment |
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Pregnancy Complications Pregnancy Outcome Congenital Abnormalities | Biological: Observational Intervention |
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 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 |

Group/Cohort | Intervention/treatment |
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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.
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Biological: Observational Intervention
This is an observational study, therefore no interventions are specified.
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- 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.
- Maternal Outcomes [ Time Frame: Up to 44 weeks ]Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.
- Infant Outcomes [ Time Frame: Up to 1 year of age ]Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.

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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 |
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.

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
Contact: Susan Farrish | 619-553-9255 | NHRC-VaccineRegistry@mail.mil |
United States, California | |
Naval Health Research Center | Recruiting |
San Diego, California, United States, 92106 |
Principal Investigator: | Susan Farrish | Naval Health Research Center |
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: | February 5, 2018 |
Last Verified: | February 2018 |
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 |