Last updated: 11/03/2018 10:39:26
Evaluate safety & immunogenicity of GSK Bio's influenza vaccine GSK576389A after repeated vaccination in elderly adults
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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™
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects reporting any and grade 3 solicited local adverse events (AEs)
Timeframe: During a 7-day follow-up period after vaccination
Duration of solicited local adverse events
Timeframe: During a 7-day follow-up period after vaccination
Number of subjects reporting any, grade 3 and related solicited general adverse events (AEs)
Timeframe: During a 7-day follow-up period after vaccination
Duration of solicited general adverse events
Timeframe: During a 7-day follow-up period after vaccination
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: During a 21-day follow-up period after vaccination
Secondary outcomes:
Number of subjects with any and related serious adverse events (SAEs)
Timeframe: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Number of subjects reporting any and related medically significant conditions (MSCs)
Timeframe: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Serum hemagglutination-inhibition (HI) antibody titers against each of the three vaccine strains
Timeframe: At Days 0 and 21
Number of subjects seroconverted for HI antibodies against each of the three vaccine strains
Timeframe: At Day 21
Seroconversion factors for HI antibodies against each of the three vaccine strains
Timeframe: At Day 21
Number of subjects seroprotected for HI antibodies against each of the three vaccine strains
Timeframe: At Days 0 and 21
Number of Cluster of Differentiation 4 (CD4) T-cells (per million CD4 T-cells) producing at least 2 different immune markers
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least CD40L and another immune marker
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least IFN-γ and another immune marker
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least IL-2 and another immune marker
Timeframe: At Day 0 and 21
Number of CD4 T-cells (per million CD4 T-cells) producing at least TNF-α and another immune marker
Timeframe: At Day 0 and 21
Number of Cluster of Differentiation 8 (CD8) T-cells (per million CD8 T-cells) expressing at least 2 different immune markers
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least CD40L and another immune marker
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least IFN-γ and another immune marker
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least IL-2 and another immune marker
Timeframe: At Day 0 and 21
Number of CD8 T-cells (per million CD8 T-cells) producing at least TNF-α and another immune marker
Timeframe: At Day 0 and 21
Interventions:
Biological/vaccine: Fluarix
Biological/vaccine: GSK Biologicals Influenza Vaccine GSK576389A
Enrollment:
1252
Observational study model:
Not applicable
Primary completion date:
2007-21-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK576389A, SB218352
Collaborators
Not applicable
Study date(s)
October 2007 to June 2008
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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 .
Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- 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.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Trial location(s)
Location
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
Status
Study Complete
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Study Complete
Location
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
Status
Study Complete
Location
GSK Investigational Site
Milford, Massachusetts, United States, 01757
Status
Study Complete
Location
GSK Investigational Site
Chaska, Minnesota, United States, 55318
Status
Study Complete
Location
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-21-12
Actual study completion date
2008-04-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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