Adenovirus Vaccine Pregnancy Registry

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01584037

Enrollment

Registered

2012-04-24

Start date

2011-12-31

Completion date

2014-04-30

Last updated

2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenovirus

Keywords

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

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

17 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Pregnancy Outcome by observation	12 months	Infants up to 12 months of age

Countries

United States

Outcome results