Adenovirus Vaccine Pregnancy Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Adenovirus

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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:

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

* Patients not willing to meet Registry study conditions and requirements.