Adenovirus Vaccine Pregnancy Registry

Teva Pharmaceuticals

Status: Withdrawn

Conditions: Adenovirus

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01584037

DR-501-401

Details and patient eligibility

About

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.

Sex: Female

Ages: 17 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Observational

Description:

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.