BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Emergent BioSolutions

Status: Completed

Conditions: Pregnancy Complications; Congenital Abnormalities; Pregnancy Outcome

Treatments: Biological: Observational Intervention

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01653392

EBS.AVA.010 / NHRC.2012.0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

98 participants in 1 patient group

Anthrax Vaccine Adsorbed

Description:

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.

Treatment:

Biological: Observational Intervention