Influenza
Conditions
Keywords
Influenza
Brief summary
This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.
Interventions
BIOLOGICALFluarix™/Influsplit SSW®
Single intramuscular dose on Day 0
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 years or above at the time of the vaccination. * Written informed consent obtained from the subject. * Healthy subjects or with well-controlled chronic diseases 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
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. * Administration of an influenza vaccine within 6 months preceding the study start. * Administration of an influenza vaccine other than the study vaccine during the entire study * Clinically or virologically confirmed influenza infection within 6 months preceding the study start * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Acute disease at the time of enrolment. * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Not stabilized or clinically serious chronic underlying disease. * Lactating female. * History of chronic alcohol consumption and/or drug abuse. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection Power | Day 21 | Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40 |
| Hemagglutination Inhibition (HI) Antibody Titer | Day 0 and Day 21 | Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains |
| Number of Seroprotected Subjects | Day 0 and Day 21 | A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40 |
| Number of Seroconverted Subjects | Day 21 | A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4 |
| Seroconversion Factor | Day 21 | Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited General Symptoms | During the 4-day (Day 0-3) post-vaccination period | Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever. |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | During the 21-day (Day 0-20) post-vaccination period | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product |
| Number of Subjects Reporting Serious Adverse Events (SAE) | During the entire study period (From Day 0 up to Day 21) | An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Number of Subjects Reporting Solicited Local Symptoms | During the 4-day (Day 0-3) post-vaccination period | Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluarix Adult Group Subjects aged 18 to 60 years received one dose of Fluarix™. | 60 |
| Fluarix Elderly Group Subjects aged \> 60 years received one dose of Fluarix™. | 54 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Fluarix Adult Group | Fluarix Elderly Group | Total |
|---|---|---|---|
| Age, Continuous | 37.1 Years STANDARD_DEVIATION 13.1 | 68.6 Years STANDARD_DEVIATION 5.08 | 52.1 Years STANDARD_DEVIATION 18.83 |
| Sex: Female, Male Female | 32 Participants | 26 Participants | 58 Participants |
| Sex: Female, Male Male | 28 Participants | 28 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 50 / 60 | 30 / 54 |
| serious Total, serious adverse events | 0 / 60 | 0 / 54 |
Outcome results
Primary
Hemagglutination Inhibition (HI) Antibody Titer
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Time frame: Day 0 and Day 21
Population: Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | A/California (Day 0) | 10.2 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | A/California (Day 21) | 314.1 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Victoria (Day 0) | 15.2 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Victoria (Day 21) | 89.6 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 0) | 36.3 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 21) | 271.6 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 0) | 42.1 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/California (Day 0) | 8.7 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Victoria (Day 21) | 75.4 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/California (Day 21) | 89.4 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 21) | 132.3 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Victoria (Day 0) | 10.5 titer |
Primary
Number of Seroconverted Subjects
A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
Time frame: Day 21
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Adult Group | Number of Seroconverted Subjects | A/Victoria | 35 Participants |
| Fluarix Adult Group | Number of Seroconverted Subjects | A/California | 50 Participants |
| Fluarix Adult Group | Number of Seroconverted Subjects | B/Brisbane | 33 Participants |
| Fluarix Elderly Group | Number of Seroconverted Subjects | A/Victoria | 36 Participants |
| Fluarix Elderly Group | Number of Seroconverted Subjects | A/California | 35 Participants |
| Fluarix Elderly Group | Number of Seroconverted Subjects | B/Brisbane | 18 Participants |
Primary
Number of Seroprotected Subjects
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
Time frame: Day 0 and Day 21
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Adult Group | Number of Seroprotected Subjects | A/California (Day 0) | 9 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | A/California (Day 21) | 54 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | A/Victoria (Day 0) | 14 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | A/Victoria (Day 21) | 48 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | B/Brisbane (Day 0) | 29 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | B/Brisbane (Day 21) | 55 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | B/Brisbane (Day 0) | 29 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/California (Day 0) | 4 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/Victoria (Day 21) | 45 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/California (Day 21) | 41 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | B/Brisbane (Day 21) | 47 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/Victoria (Day 0) | 7 Participants |
Primary
Seroconversion Factor
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
Time frame: Day 21
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluarix Adult Group | Seroconversion Factor | A/California | 30.8 fold change |
| Fluarix Adult Group | Seroconversion Factor | A/Victoria | 5.9 fold change |
| Fluarix Adult Group | Seroconversion Factor | B/Brisbane | 7.5 fold change |
| Fluarix Elderly Group | Seroconversion Factor | A/California | 10.3 fold change |
| Fluarix Elderly Group | Seroconversion Factor | A/Victoria | 7.2 fold change |
| Fluarix Elderly Group | Seroconversion Factor | B/Brisbane | 3.1 fold change |
Primary
Seroprotection Power
Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40
Time frame: Day 21
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Adult Group | Seroprotection Power | A/California | 45 Participants |
| Fluarix Adult Group | Seroprotection Power | A/Victoria | 34 Participants |
| Fluarix Adult Group | Seroprotection Power | B/Brisbane | 26 Participants |
| Fluarix Elderly Group | Seroprotection Power | A/California | 37 Participants |
| Fluarix Elderly Group | Seroprotection Power | A/Victoria | 38 Participants |
| Fluarix Elderly Group | Seroprotection Power | B/Brisbane | 18 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the entire study period (From Day 0 up to Day 21)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix Adult Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 0 Participants |
Secondary
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.
Time frame: During the 4-day (Day 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 13 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Shivering | 5 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 6 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Fever (Axillary) | 1 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 11 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Sweating | 3 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 11 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Sweating | 3 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 4 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 8 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 9 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Shivering | 3 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Fever (Axillary) | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 9 Participants |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
Time frame: During the 4-day (Day 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Induration | 9 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 10 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 40 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 8 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Ecchymosis | 3 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 7 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Ecchymosis | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Induration | 9 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 17 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 15 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time frame: During the 21-day (Day 0-20) post-vaccination period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix Adult Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 12 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 6 Participants |