Back to resultsEvaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GSK Bio's influenza vaccine GSK2186877A
Fluarix
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Elderly
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
- Written informed consent obtained from the subject.
- Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- Female subjects must be of non-childbearing potential.
Exclusion Criteria:
- 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.
- 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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
- Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensivity 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 clinical evaluation (medical history and medical history directed 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 administration of the study vaccine or planned administration during the study.
- Any medical conditions in which IM injections are contraindicated.
- Lactating female, female planning to become pregnant or planning 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
New generation influenza vaccine GSK2186877A Group
Fluarix elderly Group
Fluarix young Group
Arm Description
Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
Subjects aged ≥65 years received 1 dose of Fluarix vaccine
Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited adverse event (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 was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20
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. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179
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. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209
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. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Secondary Outcome Measures
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody Titers at Day 180
Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seropositive to HI Antibodies at Day 180
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroconverted to HI Antibodies at Day 21
Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroconverted to HI Antibodies at Day 180
Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody Seroconversion Factor (SCF) at Day 21
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody SCF at Day 180
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21
Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroprotected to HI Antibodies at Day 180
Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00760617
Brief Title
Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older
Official Title
Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 6, 2008 (undefined)
Primary Completion Date
May 15, 2009 (Actual)
Study Completion Date
May 15, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.
This protocol posting deals with objectives & outcome measures of the extension phase at year 1. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Elderly
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
526 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New generation influenza vaccine GSK2186877A Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
Arm Title
Fluarix elderly Group
Arm Type
Active Comparator
Arm Description
Subjects aged ≥65 years received 1 dose of Fluarix vaccine
Arm Title
Fluarix young Group
Arm Type
Active Comparator
Arm Description
Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Intervention Type
Biological
Intervention Name(s)
GSK Bio's influenza vaccine GSK2186877A
Intervention Description
Intramuscular (IM) administration, 1 dose
Intervention Type
Biological
Intervention Name(s)
Fluarix
Intervention Description
Intramuscular (IM) administration, 1 dose
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Description
Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Time Frame
Day 0-6
Title
Duration of Solicited Local AEs
Description
Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.
Time Frame
Day 0-6
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Description
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
Day 0-6
Title
Duration of Solicited General AEs
Description
Duration was defined as number of days with any grade of general symptoms.
Time Frame
Day 0-6
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Description
Unsolicited adverse event (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 was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.
Time Frame
Day 0-20
Title
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20
Description
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Time Frame
Day 0-20
Title
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179
Description
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Time Frame
Day 21-179
Title
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)
Description
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.
Time Frame
Day 0-179
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20
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. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Time Frame
Day 0-20
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179
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. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Time Frame
Day 21-179
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209
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. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Time Frame
Day 180 to Day 209
Secondary Outcome Measure Information:
Title
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Description
Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
At Day 0 and 21
Title
HI Antibody Titers at Day 180
Description
Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 180
Title
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21
Description
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
At Day 0 and 21
Title
The Number of Subjects Seropositive to HI Antibodies at Day 180
Description
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 180
Title
The Number of Subjects Seroconverted to HI Antibodies at Day 21
Description
Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 21
Title
The Number of Subjects Seroconverted to HI Antibodies at Day 180
Description
Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 180
Title
HI Antibody Seroconversion Factor (SCF) at Day 21
Description
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 21
Title
HI Antibody SCF at Day 180
Description
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 180
Title
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21
Description
Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
At Day 0 and 21
Title
The Number of Subjects Seroprotected to HI Antibodies at Day 180
Description
Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 180
Title
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
Description
The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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 that they can and will comply with the requirements of the protocol.
A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
Written informed consent obtained from the subject.
Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Female subjects must be of non-childbearing potential.
Exclusion Criteria:
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.
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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of hypersensivity 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 clinical evaluation (medical history and medical history directed 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 administration of the study vaccine or planned administration during the study.
Any medical conditions in which IM injections are contraindicated.
Lactating female, female planning to become pregnant or planning 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
Gueglingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74363
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68161
Country
Germany
Facility Name
GSK Investigational Site
City
Rudersberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73635
Country
Germany
Facility Name
GSK Investigational Site
City
Weinheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69469
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51069
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Rhaunen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55624
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
Facility Name
GSK Investigational Site
City
Wolmirstedt
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39326
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
GSK Investigational Site
City
Freital
State/Province
Sachsen
ZIP/Postal Code
01705
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10435
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13359
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22335
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3001 DC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3011 EN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Eskilstuna
ZIP/Postal Code
SE-631 88
Country
Sweden
Facility Name
GSK Investigational Site
City
Karlskrona
ZIP/Postal Code
SE-371 41
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
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
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111737
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
111737
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
111737
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
111737
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111737
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
111737
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
111737
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older
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