Immunologic TestsNCT01099488
A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays
A study testing Blood withdrawal in people with Immunologic Tests, run by GlaxoSmithKline at 2 sites in Belgium.
Trial summary
The purpose of this study is to develop immunological assays on blood samples. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunologic Tests
- What is being tested?
- Blood withdrawal
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Apr 2010to 7 Dec 2010
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
GSK Investigational Site
Antwerp, 2000
GSK Investigational Site
Mons, 7000
About this study
The purpose of this study is to develop immunological assays on blood samples.
Read the 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.
- Conditions
- Immunologic Tests
- Being tested
- Blood withdrawal
- Keywords
- Immunological assays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | 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. Receives: Procedure: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of CD8+ T-cells at protocol-defined time points.
Measured: At Day 0, Day 14 and Day 180.
Secondary outcomes (1)
Frequency of CD4+ T-cells response at protocol-defined time points.
Measured: At Day 0, Day 14 and Day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study start1 Apr 2010
- Primary completion7 Dec 2010
- Study completion7 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunologic TestsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099488
- Sponsor's protocol ID
- 113737
- Status last verified
- Jun 2017
- First submitted
- 26 Mar 2010
- Last updated
- 27 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays
- ClinicalTrials.gov ID
- NCT01099488
- Acronym / sponsor ID
- 113737
- Conditions
- Immunologic Tests
- Keywords
- Immunological assays
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2010
- Primary completion
- 7 Dec 2010 (actual)
- Study completion
- 7 Dec 2010 (actual)
- First posted
- 7 Apr 2010 (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 purpose of this study is to develop immunological assays on blood samples.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Procedure: Blood withdrawalHealthy 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood withdrawalHealthy 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. | Procedure or surgery | All subjects |
Primary outcome
Frequency of CD8+ T-cells at protocol-defined time points.
Time frame: At Day 0, Day 14 and Day 180.
1 secondary outcome
Frequency of CD4+ T-cells response at protocol-defined time points.
Time frame: At Day 0, Day 14 and Day 180.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood withdrawal in people with Immunologic Tests, run by GlaxoSmithKline at 2 sites in Belgium.
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 19 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: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of CD8+ T-cells at protocol-defined time points. (time frame: At Day 0, Day 14 and Day 180.). 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 27 Jun 2017.