Status:
COMPLETED
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in adults 18 year...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject
- Male and female adults, 18 years of age and older in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
- 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 vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination
Exclusion
- Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
- Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Acute disease and/or fever at the time of enrolment.
- Significant acute or chronic, uncontrolled medical or psychiatric illness.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
- Insulin-dependent diabetes mellitus.
- Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study vaccine dose.
- A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
- Presence of an active neurological disorder.
- History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g. low-dose aspirin, and without a clinically apparent bleeding tendency are eligible
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- Any known or suspected allergy to any constituent of FLU-Q-QIV and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
- A history of severe adverse reaction to a previous influenza vaccination.
- Pregnant and/or lactating/nursing female.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Key Trial Info
Start Date :
September 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2011
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01440387
Start Date
September 30 2011
End Date
October 22 2011
Last Update
September 7 2018
Active Locations (1)
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1
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1