Adenovirus Vaccine Pregnancy Registry

Withdrawn

• Conditions: Adenovirus

• Registration Number: NCT01584037
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-17
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Pregnancy Outcome by observation	12 months	Infants up to 12 months of age

Trial Locations

Locations (1)

INC Research, LLC (Registry Coordinating Center); 🇺🇸 Wilmington, North Carolina, United States