NCT01702272

Completed

Procleix® Dengue Virus Assay Testing of Individual Donor Sam...

Gen-Probe, Incorporated Source

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Other study identifiers

Sponsor study identifier

DENVTS-US12-002

Study Type

observational

Estimated enrollment

150,000

Locations

1 country

Sites

1

Timeline

Study Start

January 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2014

Actual (reported)

Study Completion

January 2014

Actual (reported)

Brief Summary

The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 150,000 participants
Study completion date: January 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 3, 2012
Actual (reported)
First Posted
October 8, 2012
Actual (reported)
Study Start
January 2013
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)
Study Completion
January 2014
Actual (reported)

Last Updated: September 15, 2014
Status Verified: September 2014
Last Update Submitted: September 11, 2014

Conditions

Dengue

Outcome Measures

Primary Outcomes (1)

Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.
Approximately three years

Study Arms (1)

Dengue Virus

Device: Procleix Dengue Virus Assay

Interventions

Procleix Dengue Virus AssayDevice

in vitro diagnostic assay

Dengue Virus

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

volunteer blood donors from the US and Puerto Rico

You may qualify if:

Donor must meet all the blood collection sites' standard eligibility requirements.

Sponsors & Collaborators

Gen-Probe, Incorporated
Industrylead

Study Sites (1)

Creative Testing Solutions - Tampa

St. Petersburg, Florida, 33716, United States

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

Jennifer Reid, PhD
Gen-Probe, Incorporated
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 8, 2012

Study Start

January 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2014

Actual (reported)

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Phase 1Completed

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NCT01666652

A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults

Phase 1Completed

NCT01072786

Evaluation of the Safety and Immune Response of Five Admixtures of a Tetravalent Dengue Virus Vaccine

Phase 1Completed

NCT00831012

Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31-7164) in Healthy Adults

Phase 1Completed

Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.

Contact the study team to confirm eligibility.

Study Completion

January 2014

Actual (reported)

Last Updated

September 15, 2014

Record last verified: 2014-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01702272
Data provider: ClinicalTrials.gov
Source updated: 2014-09-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:59 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Dengue Virus

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations