Adenovirus Vaccine Pregnancy Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 17 - 50 |
| Updated: | 5/3/2014 |
| Start Date: | December 2011 |
| End Date: | March 2017 |
| Contact: | Angie O Graves, MBA |
| Email: | angie.graves@incresearch.com |
| Phone: | 866.790.4549 |
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.
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.
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.
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