A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays

GlaxoSmithKline1 site in 1 country46 target enrollmentApril 1, 2010

ConditionsImmunologic Tests

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immunologic Tests
Sponsor: GlaxoSmithKline
Enrollment: 46
Locations: 1
Primary Endpoint: Frequency of CD8+ T-cells at protocol-defined time points.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2010

End Date

December 7, 2010

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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
•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
•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
•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).