Adenovirus Vaccine Pregnancy Registry

Adenovirus Clinical Trial

Official title:

Adenovirus Vaccine Pregnancy Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01584037
• Other study ID #: DR-501-401
• Status: Withdrawn
• Phase: N/A
• First received: April 20, 2012
• Last updated: April 17, 2014
• Start date: December 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 50 Years

Eligibility

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 ß-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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus

Locations

Country	Name	City	State
United States	INC Research, LLC (Registry Coordinating Center)	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Pregnancy Outcome by observation	Infants up to 12 months of age	12 months	Yes