Back to resultsStudy to Evaluate an Influenza Vaccine Candidate
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Influenza Vaccine GSK1247446A - 4 different formulations
Fluarix™
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Influenza Vaccine
Eligibility Criteria
Inclusion Criteria:
- Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
- A male or female between, and including, 18 - 64 years of age at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects 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 have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
- Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine within a year preceding the study start.
- 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.
- Pregnant or lactating female.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Acute disease at the time of enrolment.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
GSK1247446A 1 Group
GSK1247446A 2 Group
GSK1247446A 3 Group
GSK1247446A 4 Group
Fluarix Group
Arm Description
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Outcomes
Primary Outcome Measures
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
Secondary Outcome Measures
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated 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 four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination
Number of Subjects With 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 unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00540228
Brief Title
Study to Evaluate an Influenza Vaccine Candidate
Official Title
Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 5, 2007 (Actual)
Primary Completion Date
May 8, 2008 (Actual)
Study Completion Date
May 8, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
Detailed Description
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
Influenza, Influenza Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1006 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1247446A 1 Group
Arm Type
Experimental
Arm Description
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A 2 Group
Arm Type
Experimental
Arm Description
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A 3 Group
Arm Type
Experimental
Arm Description
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A 4 Group
Arm Type
Experimental
Arm Description
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Arm Title
Fluarix Group
Arm Type
Active Comparator
Arm Description
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine GSK1247446A - 4 different formulations
Intervention Description
Single dose, Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Fluarix™
Intervention Description
Single dose, Intramuscular injection
Primary Outcome Measure Information:
Title
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Description
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
Time Frame
At Days 0, 21 and 180
Secondary Outcome Measure Information:
Title
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Description
A seroconverted subject was defined as a vaccinated 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 four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Time Frame
At Days 21 and 180
Title
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Description
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Time Frame
At Days 21 and 180
Title
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Description
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Time Frame
At Days 0, 21 and 180
Title
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Description
Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.
Time Frame
At Days 0 and 21
Title
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Description
The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Time Frame
At Days 0, 21 and 180
Title
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Description
The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Time Frame
At Days 0, 21 and 180
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Description
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
Time Frame
During the 7-day (Days 0-6) post vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Description
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Time Frame
During the 7-day (Days 0-6) post vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
Description
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination
Time Frame
From Day 0 to Day 180
Title
Number of Subjects With 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 unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Time Frame
During the 21-day (Days 0-20) post vaccination period
Title
Number of Subjects With Serious Adverse Events (SAEs).
Description
Serious adverse events (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
From Day 0 to Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
A male or female between, and including, 18 - 64 years of age at the time of vaccination.
Written informed consent obtained from the subject.
Healthy subjects 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 have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
History of hypersensitivity to a previous dose of influenza vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Confirmed influenza infection within a year preceding the study start.
Administration of an influenza vaccine within a year preceding the study start.
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.
Pregnant or lactating female.
Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
Acute disease at the time of enrolment.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
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
Caen cedex 4
ZIP/Postal Code
14052
Country
France
Facility Name
GSK Investigational Site
City
Lagord
ZIP/Postal Code
17140
Country
France
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59019
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
GSK Investigational Site
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
GSK Investigational Site
City
Tuebingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72074
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Freiberg
State/Province
Sachsen
ZIP/Postal Code
09599
Country
Germany
Facility Name
GSK Investigational Site
City
Schmiedeberg
State/Province
Sachsen
ZIP/Postal Code
01762
Country
Germany
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
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.
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
110794
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
110794
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
110794
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
110794
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
110794
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
110794
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study to Evaluate an Influenza Vaccine Candidate
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