AdenovirusNCT01584037
Adenovirus Vaccine Pregnancy Registry
An observational study of Adenovirus, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenovirus
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2014
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will consist of: 1. 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 2. Infants born to females with confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, followed through one year post delivery.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
INC Research, LLC (Registry Coordinating Center)
Wilmington, North Carolina, 28405
About this study
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.
- Conditions
- Adenovirus
- Keywords
- Adenovirus, Adenovirus Type 4, Adenovirus Type 7, Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Pregnancy Outcome by observation
Infants up to 12 months of age
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Vikki Brown, MD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584037
- Sponsor's protocol ID
- DR-501-401
- Status last verified
- Apr 2014
- First submitted
- 20 Apr 2012
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenovirus Vaccine Pregnancy Registry
- ClinicalTrials.gov ID
- NCT01584037
- Acronym / sponsor ID
- DR-501-401
- Conditions
- Adenovirus
- Keywords
- Adenovirus, Adenovirus Type 4, Adenovirus Type 7, Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of: 1. 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 2. Infants born to females with confirmed exposure to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, followed through one year post delivery.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Pregnancy Outcome by observation
Time frame: 12 months
Infants up to 12 months of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikki Brown, MD principal investigator
Syneos Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenovirus, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Pregnancy Outcome by observation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.