Back to resultsEvaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Influenza vaccine GSK2186877A
GSK Biologicals' Fluarix™
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Elderly, Vaccine, Influenza
Eligibility Criteria
Inclusion Criteria:
- A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
- Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by medical history and clinical 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, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
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 2008 with any seasonal influenza vaccine.
- 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.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccines.
- 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 administration of the study vaccine or planned administration during the study period.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
- Any medical conditions in which intramuscular injections are contraindicated.
- Pregnant or lactating females.
- 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
- 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 ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
Subjects aged ≥66 years received one dose of Fluarix vaccine.
Subjects aged 19-43 years received one 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 were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
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 ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms 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 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 defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 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 a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20
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 autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From 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 an event assessed by the investigator as causally related to the study vaccination.
Secondary Outcome Measures
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 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 a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364
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 autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seropositive to HI Antibodies
A seropositive subject was defined as a subject with 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 Seroprotected by HI Antibodies
A seroprotected subject was defined as a subject with a serum HI titer ≥ 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 Seroconverted to HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody Seroconversion Factors (SCF)
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.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364
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 an event assessed by the investigator as causally related to the study vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00772889
Brief Title
Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
Official Title
Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 9, 2008 (undefined)
Primary Completion Date
December 15, 2009 (Actual)
Study Completion Date
December 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 observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Elderly, Vaccine, Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
971 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New generation influenza vaccine GSK2186877A Group
Arm Type
Experimental
Arm Description
Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
Arm Title
Fluarix elderly Group
Arm Type
Active Comparator
Arm Description
Subjects aged ≥66 years received one dose of Fluarix vaccine.
Arm Title
Fluarix young Group
Arm Type
Active Comparator
Arm Description
Subjects aged 19-43 years received one dose of Fluarix vaccine.
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine GSK2186877A
Intervention Description
One intramuscularly injection at Day 0
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' Fluarix™
Intervention Description
One intramuscularly injection at Day 0
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 were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.
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.
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 ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms 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 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 defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally 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 (MAEs) During Day 0 to Day 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 a 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 0-20
Title
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20
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 autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.
Time Frame
Day 0-20
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From 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 an event assessed by the investigator as causally related to the study vaccination.
Time Frame
Day 0-20
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 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 a 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 21-179
Title
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364
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 autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a 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 21-364.
Title
Haemagglutination Inhibition (HI) Antibody Titers
Description
Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 0-21
Title
The Number of Subjects Seropositive to HI Antibodies
Description
A seropositive subject was defined as a subject with 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 0-21
Title
The Number of Subjects Seroprotected by HI Antibodies
Description
A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
Day 0-21
Title
The Number of Subjects Seroconverted to HI Antibodies
Description
A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time Frame
At Day 21
Title
HI Antibody Seroconversion Factors (SCF)
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
At Day 21
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364
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 an event assessed by the investigator as causally related to the study vaccination.
Time Frame
Day 21-364
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by medical history and clinical 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, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
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 2008 with any seasonal influenza vaccine.
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.
History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccines.
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 administration of the study vaccine or planned administration during the study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
Any medical conditions in which intramuscular injections are contraindicated.
Pregnant or lactating females.
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
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
5528
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
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111738
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
111738
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
111738
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
111738
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
111738
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
111738
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
111738
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 the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
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