Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/10/2018 |
Start Date: | October 15, 2007 |
End Date: | June 4, 2008 |
Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™
Since influenza vaccines are administered every year because of the frequent change in their
antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza
vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this
observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will
receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only
subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for
participation in this study.
antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza
vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this
observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will
receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only
subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for
participation in this study.
This study involves 2 age groups (based on primary study):
Subjects enrolled in the >= 65 yrs age group in the primary study. Subjects enrolled in the
18-40 yrs age group in the primary study. The study will be conducted in an open manner for
this age group.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Subjects enrolled in the >= 65 yrs age group in the primary study. Subjects enrolled in the
18-40 yrs age group in the primary study. The study will be conducted in an open manner for
this age group.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of
the protocol should be enrolled in the study.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical
evaluation 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, have a negative pregnancy test and continue such precautions for 2 months
after completion of the vaccination series.
- Male or female subjects who participated in the 104888 study (NCT00377585) and were
enrolled in the >= 65 years age group or in the 18-40 years age group .
Exclusion Criteria:
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol up to 30 days
after vaccination
- Planned administration of an influenza vaccine other than the study vaccines during
the entire study period
- Any vaccination against influenza since January 2007
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).
- History of hypersensitivity to a previous dose of influenza vaccine
- History of allergy or reactions likely to be exacerbated by any component of the
vaccine(s)
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or pre-existing
laboratory screening tests
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study
period
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days prior to vaccination, or planned use during the study
period
- Any medical conditions in which IM injections are contraindicated
- Pregnant or lactating female, or planning to become pregnant or to discontinue
contraceptive precautions.
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