BioThrax® (Anthrax) Vaccine in Pregnancy Registry
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2016 by Emergent BioSolutions
Sponsor:
Emergent BioSolutions
Collaborator:
Naval Health Research Center
Information provided by (Responsible Party):
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT01653392
First received: July 16, 2012
Last updated: June 16, 2016
Last verified: June 2016
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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:
MedlinePlus related topics:
Anthrax
Drug Information available for:
Anthrax Vaccine Adsorbed
U.S. FDA Resources
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | July 16, 2012 |
| Last Updated: | June 16, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on September 27, 2016