Clinical Trial: Adenovirus Vaccine Pregnancy Registry

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational [Patient Registry]

Official Title: Adenovirus Vaccine Pregnancy Registry

Brief Summary:

The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect data concerning:

  1. Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,
  2. Potential confounding factors, and
  3. 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.


Detailed Summary:
Sponsor: Teva Pharmaceutical Industries

Current Primary Outcome: Adverse Pregnancy Outcome by observation [ Time Frame: 12 months ]

Infants up to 12 months of age


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: April 20, 2012
Date Started: December 2011
Date Completion:
Last Updated: April 17, 2014
Last Verified: April 2014