Back to resultsImmunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GlaxoSmithKline Biologicals' influenza vaccine GSK576389A
Fluarix
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine GSK576389A, Influenza infection, Fluarix
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed 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:
- 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 during the entire study period.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
- Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Hypersensitivity to a previous dose of influenza vaccine.
- Allergy to any component of the vaccine.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature<37.5ºC (99.5ºF).
- 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 or female planning to become pregnant or to discontinue contraceptive precautions
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Influenza vaccine GSK576389A formulation 1 Group
Influenza vaccine GSK576389A formulation 2 Group
Influenza vaccine GSK576389A formulation 3 Group
Influenza vaccine GSK576389A formulation 4 Group
Influenza vaccine GSK576389A formulation 5 Group
Influenza vaccine GSK576389A formulation 6 Group
Influenza vaccine GSK576389A formulation 7 Group
Influenza vaccine GSK576389A formulation 8 Group
Fluarix elderly Group
Fluarix young Group
Arm Description
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of Fluarix vaccine.
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Outcomes
Primary Outcome Measures
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Secondary Outcome Measures
HI Antibody Titers at Day 0 and Day 21
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
HI Antibody Titers at Day 180
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The Number of Subjects Seroconverted to HI Antibodies at Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The Number of Subjects Seroconverted to HI Antibodies at Day 180
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
HI Antibody Seroconversion Factors at Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
HI Antibody Seroconversion Factors at Day 180
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21
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. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The Number of Subjects Seroprotected to HI Antibodies at Day 180
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. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, pain, redness and swelling was greater than 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. Any for ecchymosis, redness and swelling was >20mm.
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 axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. 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 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 or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and 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 or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit 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 or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and 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 or relation to vaccination and related was an 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 and 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 or relation to vaccination 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
NCT00540592
Brief Title
Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Official Title
Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 8, 2007 (undefined)
Primary Completion Date
June 10, 2008 (Actual)
Study Completion Date
June 10, 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 65 years and older compared to Fluarix.
Detailed Description
There are 10 parallel groups: 9 observer blinded groups with subjects 65 years and older receiving an investigational vaccine or Fluarix, and 1 open group with subjects between 18 and 40 years old receiving Fluarix. CMI response will be determined for a subset only.
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 vaccine GSK576389A, Influenza infection, Fluarix
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2007 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza vaccine GSK576389A formulation 1 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Influenza vaccine GSK576389A formulation 2 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Influenza vaccine GSK576389A formulation 3 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Influenza vaccine GSK576389A formulation 4 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Influenza vaccine GSK576389A formulation 5 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Influenza vaccine GSK576389A formulation 6 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Influenza vaccine GSK576389A formulation 7 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Influenza vaccine GSK576389A formulation 8 Group
Arm Type
Experimental
Arm Description
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
Arm Title
Fluarix elderly Group
Arm Type
Active Comparator
Arm Description
Subjects aged ≥65 years received one dose of Fluarix vaccine.
Arm Title
Fluarix young Group
Arm Type
Active Comparator
Arm Description
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Intervention Type
Biological
Intervention Name(s)
GlaxoSmithKline Biologicals' influenza vaccine GSK576389A
Intervention Description
Single dose, Intramuscular injection, 8 different formulations were tested (one per group)
Intervention Type
Biological
Intervention Name(s)
Fluarix
Intervention Description
Single dose, Intramuscular injection
Primary Outcome Measure Information:
Title
Haemagglutination Inhibition (HI) Antibody Titers
Description
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 21
Secondary Outcome Measure Information:
Title
HI Antibody Titers at Day 0 and Day 21
Description
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 0 and 21
Title
HI Antibody Titers at Day 180
Description
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 180
Title
The Number of Subjects Seroconverted to HI Antibodies at Day 21
Description
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 21
Title
The Number of Subjects Seroconverted to HI Antibodies at Day 180
Description
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 180
Title
HI Antibody Seroconversion Factors at Day 21
Description
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 21
Title
HI Antibody Seroconversion Factors at Day 180
Description
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 180
Title
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21
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. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 0 and 21
Title
The Number of Subjects Seroprotected to HI Antibodies at Day 180
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. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 180
Title
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
Description
The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Days 0 and 21
Title
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
Description
The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 180
Title
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
Description
The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Days 0 and 21
Title
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
Description
The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Time Frame
At Day 180
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Description
Grade 3 ecchymosis, pain, redness and swelling was greater than 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. Any for ecchymosis, redness and swelling was >20mm.
Time Frame
During a 7-day follow-up period (Day 0-6) after vaccination
Title
Duration of Solicited Local AEs
Description
Duration was defined as number of days with any grade of local symptoms.
Time Frame
During a 7-day follow-up period (Day 0-6) after vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Description
Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
During a 7-day follow-up period (Day 0-6) after vaccination
Title
Duration of Solicited General AEs
Description
Duration was defined as number of days with any grade of general symptoms.
Time Frame
During a 7-day follow-up period (Day 0-6) after vaccination
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 or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time Frame
During a 21-day follow-up period (Day 0-20) after vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and 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 or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
Between Day 0 and Day 20 after vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit 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 or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Time Frame
Between Day 21 and Day 179 after vaccination
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and 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 or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame
Between Day 0 and Day 20 after vaccination
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and 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 or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame
Between Day 21 and Day 179 after vaccination
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 should be enrolled in the study.
A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed 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:
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 during the entire study period.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Hypersensitivity to a previous dose of influenza vaccine.
Allergy to any component of the vaccine.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature<37.5ºC (99.5ºF).
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 or female planning to become pregnant or to discontinue contraceptive precautions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
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
3011 EN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GE
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
Facility Name
GSK Investigational Site
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Buckshaw Village, Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Clydebank, Glasgow
ZIP/Postal Code
G81 2DR
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edgbaston, Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Waterloo, Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
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
23890405
Citation
Rumke HC, Richardus JH, Rombo L, Pauksens K, Plassmann G, Durand C, Devaster JM, Dewe W, Oostvogels L. Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial. BMC Infect Dis. 2013 Jul 26;13:348. doi: 10.1186/1471-2334-13-348.
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
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110847
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
110847
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
110847
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
110847
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
110847
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
110847
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
110847
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
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