Adenovirus Vaccine Pregnancy Registry
The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect data concerning:
- Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,
- Potential confounding factors, and
- The outcome of these pregnancies.
The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the frequency of birth defects in prospectively enrolled pregnant women. This Registry is also designed to detect any unusual patterns of birth defects.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Time Perspective: Prospective|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Adenovirus Vaccine Pregnancy Registry|
- Adverse Pregnancy Outcome by observation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Infants up to 12 months of age
|Study Start Date:||December 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
This is a prospective, observational, exposure-registration and follow-up study of pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral and their live born offspring through the first year of life. The intent of the Adenovirus Vaccine Pregnancy Registry, Protocol DR-501-401, is to collect observational data on pregnancy outcomes, including birth defects, in women who were exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584037
|United States, North Carolina|
|INC Research, LLC (Registry Coordinating Center)|
|Wilmington, North Carolina, United States, 28405|
|Principal Investigator:||Vikki Brown, MD||INC Research|