Adenovirus Vaccine Pregnancy Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01584037|
Recruitment Status : Withdrawn
First Posted : April 24, 2012
Last Update Posted : April 21, 2014
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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||0 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Adenovirus Vaccine Pregnancy Registry|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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.
- Adverse Pregnancy Outcome by observation [ Time Frame: 12 months ]Infants up to 12 months of age
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584037
|United States, North Carolina|
|INC Research, LLC (Registry Coordinating Center)|
|Wilmington, North Carolina, United States, 28405|
|Principal Investigator:||Vikki Brown, MD||INC Research|