Back to resultsClinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GSK Biologicals' influenza vaccine GSK2186877A
GSK Biologicals' Fluarix
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Vaccine, Elderly, Influenza
Eligibility Criteria
Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. 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.
Elderly adults:
• A man or woman 65 year of age or older at the time of the first vaccination.
Young adults:
- Man or woman between the ages of 18 and 40 years, inclusive.
- If the subject is female, she must be of non-childbearing potential or be post-menopausal, 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 vaccination.
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 a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4.
- Vaccination against influenza since February 2008 with a seasonal influenza vaccine.
- Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic 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 hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg or chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation 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 intramuscular injections are contraindicated.
- Pregnant or lactating female.
- Female of childbearing age planning to become pregnant or planning to discontinue contraceptive precautions.
- Any medical condition that in the opinion of the investigator precludes the collection of blood volumes as required by the protocol.
Sites / Locations
- 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 receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Outcomes
Primary Outcome Measures
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)
Secondary Outcome Measures
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
Haemagglutinin Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10
The Number of Subjects Seroconverted to HI Antibodies
Seroconversion was defined as the number of vaccinees who had either a prevaccination 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.
HI Antibody Seroconversion Factors
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
The Number of Subjects Seroprotected to HI Antibodies
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.
Duration of Solicited Local AEs
Duration was defined as the 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 defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was 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 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 or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
For each solicited and unsolicited AE the subject experienced, the subject was asked if they 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 or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.
Number of Subjects Reporting Any AEs of Specific Interest (AESI)
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 or relation to vaccination.
Number of Subjects Reporting 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. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00765076
Brief Title
Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
Official Title
Observer-blind Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 16, 2008 (undefined)
Primary Completion Date
December 4, 2009 (Actual)
Study Completion Date
December 4, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.
Detailed Description
The amendment to the protocol posting: minor change in one inclusion criterion and in one secondary outcome measure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Vaccine, Elderly, Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New generation influenza vaccine GSK2186877A Group
Arm Type
Experimental
Arm Description
Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
Arm Title
Fluarix elderly Group
Arm Type
Active Comparator
Arm Description
Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
Arm Title
Fluarix young Group
Arm Type
Active Comparator
Arm Description
Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' influenza vaccine GSK2186877A
Intervention Description
One intramuscular injection at Day 0
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' Fluarix
Intervention Description
One intramuscular injection at Day 0
Primary Outcome Measure Information:
Title
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers
Description
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers
Description
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
Time Frame
At Day 0, 21, 42 and 180
Title
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker
Description
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
Time Frame
At Day 0, 21, 42 and 180
Title
Haemagglutinin Inhibition (HI) Antibody Titers
Description
Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.
Time Frame
At Day 0, 21, 42 and 180
Title
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.
Description
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10
Time Frame
At Day 0, 21, 42 and 180
Title
The Number of Subjects Seroconverted to HI Antibodies
Description
Seroconversion was defined as the number of vaccinees who had either a prevaccination 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.
Time Frame
At Day 21, 42 and 180
Title
HI Antibody Seroconversion Factors
Description
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
Time Frame
At Day 21, 42 and 180
Title
The Number of Subjects Seroprotected to HI Antibodies
Description
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Time Frame
At Day 0, 21, 42 and 180
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Description
Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.
Time Frame
Day 0 -6
Title
Duration of Solicited Local AEs
Description
Duration was defined as the 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 defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was 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 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 or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by 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)
Description
For each solicited and unsolicited AE the subject experienced, the subject was asked if they 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 or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.
Time Frame
Day 0-179
Title
Number of Subjects Reporting Any AEs of Specific Interest (AESI)
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 or relation to vaccination.
Time Frame
Day 0-364
Title
Number of Subjects Reporting 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. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.
Time Frame
Day 0-364
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. 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.
Elderly adults:
• A man or woman 65 year of age or older at the time of the first vaccination.
Young adults:
Man or woman between the ages of 18 and 40 years, inclusive.
If the subject is female, she must be of non-childbearing potential or be post-menopausal, 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 vaccination.
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 a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4.
Vaccination against influenza since February 2008 with a seasonal influenza vaccine.
Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic 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 hypersensivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg or chicken protein.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation 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 intramuscular injections are contraindicated.
Pregnant or lactating female.
Female of childbearing age planning to become pregnant or planning to discontinue contraceptive precautions.
Any medical condition that in the opinion of the investigator precludes the collection of blood volumes as required by the protocol.
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
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Marid
ZIP/Postal Code
28040
Country
Spain
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.
Citations:
PubMed Identifier
25078387
Citation
Couch RB, Bayas JM, Caso C, Mbawuike IN, Lopez CN, Claeys C, El Idrissi M, Herve C, Laupeze B, Oostvogels L, Moris P. Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older. BMC Infect Dis. 2014 Jul 30;14:425. doi: 10.1186/1471-2334-14-425.
Results Reference
derived
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
112147
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
112147
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
112147
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
112147
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
112147
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
112147
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
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