Influenza
Conditions
Keywords
Influenza
Brief summary
This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 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 |
| Number of Subjects With HI Antibody Titer Above the Cut-off Value | Day 0 and Day 21 | The cut-off value assessed was ≥ 1:10 and was 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 |
| 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 |
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 | 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 who are 18-60 years of age received one dose of Fluarix™ | 61 |
| Fluarix Elderly Group Subjects who are \> 60 years of age received one dose of Fluarix™ | 57 |
| Total | 118 |
Baseline characteristics
| Characteristic | Fluarix Adult Group | Fluarix Elderly Group | Total |
|---|---|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 12.18 | 68.9 years STANDARD_DEVIATION 6.57 | 53.6 years STANDARD_DEVIATION 17.82 |
| Sex: Female, Male Female | 32 Participants | 28 Participants | 60 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 61 | 31 / 57 |
| serious Total, serious adverse events | 0 / 61 | 0 / 57 |
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/Brisbane (Day 0) | 15.5 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Brisbane (Day 21) | 139.7 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Uruguay (Day 0) | 18.2 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Uruguay (Day 21) | 151.7 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 0) | 62.8 titer |
| Fluarix Adult Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 21) | 393.0 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 0) | 77.6 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Brisbane (Day 0) | 11.4 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Uruguay (Day 21) | 112.4 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Brisbane (Day 21) | 55.8 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | B/Brisbane (Day 21) | 371.3 titer |
| Fluarix Elderly Group | Hemagglutination Inhibition (HI) Antibody Titer | A/Uruguay (Day 0) | 13.2 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/Brisbane | 41 Participants |
| Fluarix Adult Group | Number of Seroconverted Subjects | A/Uruguay | 40 Participants |
| Fluarix Adult Group | Number of Seroconverted Subjects | B/Brisbane | 34 Participants |
| Fluarix Elderly Group | Number of Seroconverted Subjects | A/Brisbane | 24 Participants |
| Fluarix Elderly Group | Number of Seroconverted Subjects | A/Uruguay | 41 Participants |
| Fluarix Elderly Group | Number of Seroconverted Subjects | B/Brisbane | 30 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/Brisbane (Day 0) | 18 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | A/Brisbane (Day 21) | 53 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | A/Uruguay (Day 0) | 17 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | A/Uruguay (Day 21) | 52 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | B/Brisbane (Day 0) | 38 Participants |
| Fluarix Adult Group | Number of Seroprotected Subjects | B/Brisbane (Day 21) | 59 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | B/Brisbane (Day 0) | 45 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/Brisbane (Day 0) | 6 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/Uruguay (Day 21) | 46 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/Brisbane (Day 21) | 35 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | B/Brisbane (Day 21) | 56 Participants |
| Fluarix Elderly Group | Number of Seroprotected Subjects | A/Uruguay (Day 0) | 10 Participants |
Primary
Number of Subjects With HI Antibody Titer Above the Cut-off Value
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
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 Subjects With HI Antibody Titer Above the Cut-off Value | A/Brisbane (Day 0) | 39 Participants |
| Fluarix Adult Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | A/Brisbane (Day 21) | 58 Participants |
| Fluarix Adult Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | A/Uruguay (Day 0) | 44 Participants |
| Fluarix Adult Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | A/Uruguay (Day 21) | 59 Participants |
| Fluarix Adult Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | B/Brisbane (Day 0) | 56 Participants |
| Fluarix Adult Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | B/Brisbane (Day 21) | 59 Participants |
| Fluarix Elderly Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | B/Brisbane (Day 0) | 54 Participants |
| Fluarix Elderly Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | A/Brisbane (Day 0) | 36 Participants |
| Fluarix Elderly Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | A/Uruguay (Day 21) | 56 Participants |
| Fluarix Elderly Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | A/Brisbane (Day 21) | 56 Participants |
| Fluarix Elderly Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | B/Brisbane (Day 21) | 56 Participants |
| Fluarix Elderly Group | Number of Subjects With HI Antibody Titer Above the Cut-off Value | A/Uruguay (Day 0) | 37 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/Brisbane | 9.0 fold change |
| Fluarix Adult Group | Seroconversion Factor | A/Uruguay | 8.3 fold change |
| Fluarix Adult Group | Seroconversion Factor | B/Brisbane | 6.3 fold change |
| Fluarix Elderly Group | Seroconversion Factor | A/Brisbane | 4.9 fold change |
| Fluarix Elderly Group | Seroconversion Factor | A/Uruguay | 8.5 fold change |
| Fluarix Elderly Group | Seroconversion Factor | B/Brisbane | 4.8 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/Brisbane | 35 Participants |
| Fluarix Adult Group | Seroprotection Power | A/Uruguay | 35 Participants |
| Fluarix Adult Group | Seroprotection Power | B/Brisbane | 21 Participants |
| Fluarix Elderly Group | Seroprotection Power | A/Brisbane | 29 Participants |
| Fluarix Elderly Group | Seroprotection Power | A/Uruguay | 36 Participants |
| Fluarix Elderly Group | Seroprotection Power | B/Brisbane | 11 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
| 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 12 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Shivering | 2 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 13 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Sweating | 6 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 14 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 0 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 5 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 8 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 6 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 3 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 7 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Shivering | 2 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited General Symptoms | Sweating | 5 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Induration | 14 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 22 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 41 Participants |
| Fluarix Adult Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 9 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 | 9 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Ecchymosis | 2 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Induration | 13 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 21 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 16 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) | 9 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 3 Participants |