NCT01584037WithdrawnNot Applicable
Adenovirus Vaccine Pregnancy Registry
Teva Branded Pharmaceutical Products R&D, Inc.1 site in 1 countryStarted: December 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Adverse Pregnancy Outcome by observation
Study Overview
Brief Summary
The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect data concerning:
- Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral,
- Potential confounding factors, and
- 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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 17 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
Adverse Pregnancy Outcome by observation
Time Frame: 12 months
Infants up to 12 months of age
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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