Status:
COMPLETED
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to compare the safety of \& immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalen...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
- Access to a telephone for scheduled follow-up telephone contacts
- Ability to provide written informed consent
- Healthy subjects as established by medical history and physical examination before entering into the study
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.
Exclusion
- 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
- Receipt of systemic glucocorticoids within 30 days of study enrollment
- Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
- Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
- Previous vaccination against influenza (2007-2008 influenza season)
- History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
- History of Guillain-Barre Syndrome (GBS)
- Acute disease, febrile illness, or upper respiratory infection at screening.
- History of splenectomy
- Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus \[HIV\]) based on medical history and physical examination
- Acquired or congenital coagulation disorders or known thrombocytopenia
- Current treatment with warfarin or heparin derivatives
- Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
- Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza
Key Trial Info
Start Date :
June 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00693706
Start Date
June 2 2008
End Date
March 26 2009
Last Update
June 8 2018
Active Locations (2)
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1
GSK Investigational Site
Miami, Florida, United States, 33143
2
GSK Investigational Site
Lenexa, Kansas, United States, 66219