BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
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