Back to resultsEvaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fluarix
GSK Biologicals Influenza Vaccine GSK576389A
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Fluarix, GSK Bio's influenza vaccine GSK576389A, Influenza infection
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
FluAS25 Group
Fluarix ≥ 65 years age Group
Fluarix 18-40 years age Group
Arm Description
Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Duration of Solicited Local Adverse Events
Duration was expressed as the median number of days the symptom was experienced.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General Adverse Events
Duration was expressed as the median number of days the symptom was experienced.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.
Secondary Outcome Measures
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)
Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains
Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers
Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker
Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers
Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker
Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00529516
Brief Title
Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
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™
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 15, 2007 (undefined)
Primary Completion Date
December 21, 2007 (Actual)
Study Completion Date
June 4, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Fluarix, GSK Bio's influenza vaccine GSK576389A, Influenza infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
1252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FluAS25 Group
Arm Type
Experimental
Arm Description
Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
Arm Title
Fluarix ≥ 65 years age Group
Arm Type
Active Comparator
Arm Description
Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
Arm Title
Fluarix 18-40 years age Group
Arm Type
Active Comparator
Arm Description
Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
Intervention Type
Biological
Intervention Name(s)
Fluarix
Intervention Description
Single dose, Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals Influenza Vaccine GSK576389A
Intervention Description
Single dose, Intramuscular injection
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Description
Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Time Frame
During a 7-day follow-up period after vaccination
Title
Duration of Solicited Local Adverse Events
Description
Duration was expressed as the median number of days the symptom was experienced.
Time Frame
During a 7-day follow-up period after vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
Description
Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
During a 7-day follow-up period after vaccination
Title
Duration of Solicited General Adverse Events
Description
Duration was expressed as the median number of days the symptom was experienced.
Time Frame
During a 7-day follow-up period after vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.
Time Frame
During a 21-day follow-up period after vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
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)
Title
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)
Description
Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.
Time Frame
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)
Title
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
Description
Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time Frame
At Days 0 and 21
Title
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
Description
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time Frame
At Day 21
Title
Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains
Description
Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.
Time Frame
At Day 21
Title
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
Description
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time Frame
At Days 0 and 21
Title
Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers
Description
Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
Title
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker
Description
Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
Title
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker
Description
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Time Frame
At Day 0 and 21
Title
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker
Description
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
Title
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker
Description
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
Title
Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers
Description
Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
Title
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker
Description
Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
Title
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker
Description
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Time Frame
At Day 0 and 21
Title
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker
Description
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
Title
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker
Description
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Time Frame
At Day 0 and 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
GSK Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
GSK Investigational Site
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
GSK Investigational Site
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
GSK Investigational Site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
GSK Investigational Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
GSK Investigational Site
City
Carnegie
State/Province
Pennsylvania
ZIP/Postal Code
15106
Country
United States
Facility Name
GSK Investigational Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Messkirch
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88605
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
GSK Investigational Site
City
Haag
State/Province
Bayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
GSK Investigational Site
City
Hoehenkirchen-Siegertsbrunn
State/Province
Bayern
ZIP/Postal Code
85635
Country
Germany
Facility Name
GSK Investigational Site
City
Langquaid
State/Province
Bayern
ZIP/Postal Code
84085
Country
Germany
Facility Name
GSK Investigational Site
City
Ruedersdorf
State/Province
Brandenburg
ZIP/Postal Code
15562
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04129
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12687
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13086
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
GSK Investigational Site
City
Bekkestua
ZIP/Postal Code
1319
Country
Norway
Facility Name
GSK Investigational Site
City
Bergen
ZIP/Postal Code
5094
Country
Norway
Facility Name
GSK Investigational Site
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
GSK Investigational Site
City
Fredrikstad
ZIP/Postal Code
N-1601
Country
Norway
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
GSK Investigational Site
City
Haugesund
ZIP/Postal Code
5507
Country
Norway
Facility Name
GSK Investigational Site
City
Skien
ZIP/Postal Code
3717
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
109821
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
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