Adenovirus Vaccine Pregnancy Registry

NCT01584037•Teva Branded Pharmaceutical Products R&D, Inc.

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.

Eligibility

Age

17 - 50 years

Sex

FEMALE

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:
•Verbal and/or written informed consent obtained from the mother of the infant.
•Patients not willing to meet Registry study conditions and requirements.

Exclusion Criteria

•Patients who refuse to provide informed consent (verbal or written) to the Institutional Review Board (IRB)-approved informed consent.

Locations (1)

INC Research, LLC (Registry Coordinating Center)

Wilmington, North Carolina, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

April 1, 2014

Completion Date

April 1, 2014

Last Updated

April 21, 2014

Conditions

Adenovirus

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

NCT05664126

CytomegalovirusAdenovirus

View study

RECRUITINGPHASE2

Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

NCT03266627

AdenovirusPrimary Immune Deficiency Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adenovirus Vaccine Pregnancy Registry

Inclusion Criteria

Exclusion Criteria

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant