Adenovirus Vaccine Pregnancy Registry

NCT01584037 | Withdrawn DMC

• 1 other identifier: DR-501-401
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Adenovirus

Keywords

Adenovirus; Adenovirus Type 4; Adenovirus Type 7; Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Outcome Measures

Primary Outcomes (1)

• Adverse Pregnancy Outcome by observation

  Infants up to 12 months of age

  12 months

Study Arms (1)

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 Criteria

• Age: 17 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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:
• Verbal and/or written informed consent obtained from the mother of the infant.

You may not qualify if:

• Patients who refuse to provide informed consent (verbal or written) to the Institutional Review Board (IRB)-approved informed consent.
• Patients not willing to meet Registry study conditions and requirements.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

INC Research, LLC (Registry Coordinating Center)

Wilmington, North Carolina, 28405, United States

Location

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Vikki Brown, MD

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (1)