Adenovirus Vaccine Pregnancy Registry

April 17, 2014 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • INC Research, LLC (Registry Coordinating Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Pregnancy Outcome by observation
Time Frame: 12 months
Infants up to 12 months of age
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Vikki Brown, MD, Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-501-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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