BioThrax® (Anthrax) Vaccine in Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Emergent BioSolutions
Sponsor:
Collaborator:
Naval Health Research Center
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT01653392
First received: July 16, 2012
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention
Pregnancy Complications
Pregnancy Outcome
Congenital Abnormalities
Biological: Observational Intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:
  • Pregnancy Outcomes [ Time Frame: Up to 44 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.

  • Infant Outcomes [ Time Frame: Up to 1 year of age ] [ Designated as safety issue: Yes ]
    Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.


Estimated Enrollment: 580
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653392

Contacts
Contact: Ava Marie S Conlin, DO, MPH 619-553-9255 NHRC-VaccineRegistry@med.navy.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: Ava Marie S Conlin, DO, MPH Naval Health Research Center
  More Information

No publications provided

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01653392     History of Changes
Other Study ID Numbers: EBS.AVA.010 / NHRC.2012.0003
Study First Received: July 16, 2012
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

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
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 01, 2014