Adenovirus Vaccine Pregnancy Registry

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01584037
First received: April 20, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition
Adenovirus

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Adenovirus Vaccine Pregnancy Registry

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Adverse Pregnancy Outcome by observation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Infants up to 12 months of age


Enrollment: 0
Study Start Date: December 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational
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.

  Eligibility

Ages Eligible for Study:   17 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of:

  1. Women previously or currently enrolled in the U.S. Military who received Adenovirus Type 4 and Type 7 Vaccine, Live, Oral while pregnant or who conceived within 6 weeks of vaccine administration, and
  2. Infants born to females with confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, followed through one year post delivery.
Criteria

Inclusion Criteria:

For women:

  • U.S. Military service member, present or former
  • Confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
  • Received Adenovirus Type 4 and Type 7 Vaccine, Live, Oral while pregnant or has an estimated date of conception (DOC) within 6 weeks after receiving Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
  • Positive β-hCG test or fetal ultrasound,and
  • Verbal and/or written informed consent obtained from the patient.

For live born offspring:

  • Infant born to a woman meeting the above inclusion criteria and enrolled in the Registry, followed through one year post delivery, and
  • Verbal and/or written informed consent obtained from the mother of the infant.

Exclusion Criteria:

  • Patients who refuse to provide informed consent (verbal or written) to the Institutional Review Board (IRB)-approved informed consent.
  • Females not exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral within the inclusion criteria period.
  • Patients not willing to meet Registry study conditions and requirements.
  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: NCT01584037

Locations
United States, North Carolina
INC Research, LLC (Registry Coordinating Center)
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Vikki Brown, MD INC Research
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01584037     History of Changes
Other Study ID Numbers: DR-501-401
Study First Received: April 20, 2012
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceutical Industries:
Adenovirus
Adenovirus Type 4
Adenovirus Type 7
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Additional relevant MeSH terms:
Adenoviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014