Adenovirus Vaccine Pregnancy Registry | NCT01584037

Studies
Adenovirus Vaccine Pregnancy Registry

NCT01584037

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Withdrawn

Last Update Posted

Apr 21, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Adenovirus

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Apr 20, 2012

First Submission Date that Met QC Criteria

Apr 23, 2012

First Posted Date

Apr 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2014

Last Update Posted Date

Apr 21, 2014Estimated

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

The study population will consist of:

Women previously or currently enrolled in the U.S. Military who received Adenovirus Type 4 and Type 7 Vaccine, Live, Oral while pregnant or who conceived within 6 weeks of vaccine administration, and
Infants born to females with confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, followed through one year post delivery.

Sampling Method

Non-Probability Sample

ID	Term
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections