- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01099488
A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays
June 26, 2017 updated by: GlaxoSmithKline
The purpose of this study is to develop immunological assays on blood samples.
Study Overview
Detailed Description
This is a clinical study in which there is no vaccine administered.
It is designed for research purposes such as developing immunological assays.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antwerpen, Belgium, 2000
- GSK Investigational Site
-
Mons, Belgium, 7000
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
- A male or female between, and including, 18 and 50 years of age at study start.
- A subject having received a Yellow Fever (YF) vaccine on the day of study entry.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination performed on the day of YF vaccination.
- Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to study start, and
- has agreed to continue adequate contraception during the entire study period.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding study start, or planned use during the study period.
- Concurrently participating in another clinical study, within 3 months preceding study start and at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Clinically significant anaemia or any known condition as per medical history that would preclude the drawing of blood as described in the protocol.
- Known previous infection with YF virus.
- Previous vaccination against YF more than approximately 5 hours before the blood sampling at Visit 1.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the study start or planned administration during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs (including chloroquine) within six months prior to the study start. For corticosteroids, this will mean prednisone ≥ 10mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Receipt of live attenuated vaccines other than the YF vaccine during the period beginning 30 days preceding the blood sampling at Visit 1 or planned use during the study up to the blood sampling at Visit 2.
- Receipt of inactivated influenza vaccines (seasonal or pandemic) during the period beginning 21 days preceding the blood sampling at Visit 1 or planned use during the study up to the blood sampling at Visit 2.
- History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
- Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV, hepatitis B and hepatitis C), based on medical history and physical examination (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and medical history.
- Acute disease and/or fever at the time of enrolment.
- Known pregnant or lactating female, as per medical records.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition that may preclude the compliance to the study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: All subjects
Healthy male or female adults between, and including, 18 and 50 years of age at the time of study start, having received a GSK2231392A vaccine, were enrolled for blood withdrawal to support the development of CD8+ T cell immunological detection assays.
|
Healthy male or female adults between, and including, 18 and 50 years of age at the time of study start, having received GSK2231392A vaccine, were enrolled for blood withdrawal, at each study visit: Day 0, Day 14 and Day 180, to support the development of CD8+ T cell immunological detection assays.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of CD8+ T-cells at protocol-defined time points.
Time Frame: At Day 0, Day 14 and Day 180.
|
At Day 0, Day 14 and Day 180.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of CD4+ T-cells response at protocol-defined time points.
Time Frame: At Day 0, Day 14 and Day 180.
|
At Day 0, Day 14 and Day 180.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
December 7, 2010
Study Completion (Actual)
December 7, 2010
Study Registration Dates
First Submitted
March 26, 2010
First Submitted That Met QC Criteria
April 6, 2010
First Posted (Estimate)
April 7, 2010
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 113737
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immunologic Tests
-
National Institute of Gastroenterology, CubaUnknownColonoscopy | Occult Blood | Immunologic TestsCuba
-
GlaxoSmithKlineCompletedImmunologic TestsBelgium
-
Essenlix CorporationCompletedHematologic TestsUnited States
-
Centre Hospitalier Universitaire DijonNot yet recruiting
-
University of Illinois at Urbana-ChampaignIchuli Consulting LimitedUnknown
-
Ribe County HospitalCompleted
-
NYU Langone HealthCompleted
-
National Cancer Institute, EgyptEnrolling by invitation
-
University of ZurichCompleted
Clinical Trials on Blood withdrawal
-
Johann Wolfgang Goethe University HospitalUnknown
-
Hadassah Medical OrganizationUnknownSleep DeprivationIsrael
-
Universitair Ziekenhuis BrusselVrije Universiteit BrusselNot yet recruitingSolid Tumor | Metastasis | Pleural Effusion
-
RWTH Aachen UniversityUnknownCardiac InsufficiencyGermany
-
Maastricht Radiation OncologyUniversitaire Ziekenhuizen KU LeuvenCompletedNon Small Cell Lung CancerNetherlands, Belgium
-
University Medical Center GroningenUnknownPregnancy | Preeclampsia
-
GlaxoSmithKlineCompletedImmunologic TestsBelgium
-
Medicortex Finland OyTurku University HospitalCompleted
-
Rambam Health Care CampusUnknownVenous Thromboembolism | Non-Small Cell Lung CarcinomaIsrael