Influenza
Conditions
Keywords
Influenza
Brief summary
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Interventions
BIOLOGICALThiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose
BIOLOGICALThiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 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 65 years of age or older at the time of 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.
Exclusion criteria
* Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months. * 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. * Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination. * Planned administration of an influenza vaccine other than the study vaccines during the entire study period. * Previous vaccination against influenza with any seasonal vaccine since July 2007. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of hypersensitivity to a previous dose of influenza vaccine. * History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein. * Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Any medical conditions in which IM injections are contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | Days 0 and 21 | Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains | 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 four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| HI Antibody Seroconversion Factors | Day 21 | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | Days 0 and 21 | A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During a 7-day period after vaccination | Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. |
| Duration of Solicited Local Symptoms | During a 7-day period after vaccination | Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. |
| Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | Days 0 and 21 | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| Duration of Solicited General Symptoms | During a 7-day period after vaccination | Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During a 21-day period after vaccination | 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | During a 21-day period after vaccination | Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | During the entire study period (up to Day 21) | 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During a 7-day period after vaccination | Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination. |
Countries
Estonia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine | 360 |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine | 360 |
| Total | 720 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Total |
|---|---|---|---|
| Age, Continuous | 72 Years STANDARD_DEVIATION 5.02 | 71.7 Years STANDARD_DEVIATION 4.88 | 71.85 Years STANDARD_DEVIATION 4.95 |
| Sex: Female, Male Female | 263 Participants | 257 Participants | 520 Participants |
| Sex: Female, Male Male | 97 Participants | 103 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 303 / 360 | 321 / 360 |
| serious Total, serious adverse events | 3 / 360 | 0 / 360 |
Outcome results
Primary
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time frame: Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Solomon Islands [Day 0] | 6.0 Titer |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Solomon Islands [Day 21] | 86.5 Titer |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Wisconsin [Day 0] | 15.9 Titer |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Wisconsin [Day 21] | 613.2 Titer |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | B/Malaysia [Day 0] | 13.2 Titer |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | B/Malaysia [Day 21] | 287.5 Titer |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | B/Malaysia [Day 0] | 13.0 Titer |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Solomon Islands [Day 0] | 6.0 Titer |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Wisconsin [Day 21] | 519.3 Titer |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Solomon Islands [Day 21] | 93.1 Titer |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | B/Malaysia [Day 21] | 264.9 Titer |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains | A/Wisconsin [Day 0] | 14.9 Titer |
Secondary
Duration of Solicited General Symptoms
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Time frame: During a 7-day period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Headache (N= 109; 107) | 2.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Nausea (N= 38; 43) | 1.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Fatigue (N= 139; 143) | 2.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Shivering (N= 45; 43) | 1.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Myalgia (N= 111; 101) | 2.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Fever (N= 26; 25) | 1.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Arthralgia (N= 78; 87) | 2.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Fever (N= 26; 25) | 1.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Arthralgia (N= 78; 87) | 2.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Fatigue (N= 139; 143) | 2.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Headache (N= 109; 107) | 2.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Myalgia (N= 111; 101) | 2.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Nausea (N= 38; 43) | 1.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited General Symptoms | Shivering (N= 45; 43) | 1.0 Days |
Secondary
Duration of Solicited Local Symptoms
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Time frame: During a 7-day period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Swelling (N= 74; 90) | 3.5 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Ecchymosis (N= 7; 6) | 4.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Pain (N= 237; 246) | 3.0 Days |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Redness (N= 152; 161) | 3.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Redness (N= 152; 161) | 4.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Swelling (N= 74; 90) | 3.5 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Pain (N= 237; 246) | 3.0 Days |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Duration of Solicited Local Symptoms | Ecchymosis (N= 7; 6) | 3.0 Days |
Secondary
HI Antibody Seroconversion Factors
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time frame: Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | HI Antibody Seroconversion Factors | A/Solomon Islands | 14.3 Fold increase |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | HI Antibody Seroconversion Factors | A/Wisconsin | 38.7 Fold increase |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | HI Antibody Seroconversion Factors | B/Malaysia | 21.8 Fold increase |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | HI Antibody Seroconversion Factors | A/Solomon Islands | 15.6 Fold increase |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | HI Antibody Seroconversion Factors | A/Wisconsin | 34.8 Fold increase |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | HI Antibody Seroconversion Factors | B/Malaysia | 20.3 Fold increase |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Time frame: During a 7-day period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any pain | 237 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any ecchymosis | 7 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 ecchymosis | 0 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 2 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 152 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 10 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling | 74 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling | 1 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling | 4 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any pain | 246 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 ecchymosis | 0 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 161 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any ecchymosis | 6 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling | 90 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 12 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 1 Subjects |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study period (up to Day 21)
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 3 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
Time frame: During a 21-day period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSCs | 9 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs | 3 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSCs | 1 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSCs | 5 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs | 0 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSCs | 1 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During a 7-day period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 78 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 1 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 75 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 139 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 2 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 139 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 109 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 3 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 109 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any myalgia | 111 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 myalgia | 1 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related myalgia | 111 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any nausea | 38 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 nausea | 1 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related nausea | 37 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 45 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 1 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 45 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 34 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 0 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 34 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 myalgia | 3 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 87 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 38 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related myalgia | 99 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 2 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 85 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 0 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 143 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any nausea | 43 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 0 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 38 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 141 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 nausea | 1 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 107 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 43 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 1 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related nausea | 42 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 105 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 1 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any myalgia | 101 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 43 Subjects |
Secondary
Number of Subjects Reporting 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.
Time frame: During a 21-day period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 83 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 3 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 61 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 71 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 53 Subjects |
Secondary
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
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 four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time frame: Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands | 278 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin | 336 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains | B/Malaysia | 332 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands | 281 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin | 337 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains | B/Malaysia | 335 Subjects |
Secondary
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time frame: Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 0] | 67 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 21] | 342 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 0] | 209 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 21] | 357 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 0] | 215 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 21] | 355 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 0] | 208 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 0] | 62 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 21] | 359 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 21] | 338 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 21] | 357 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 0] | 199 Subjects |
Secondary
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Time frame: Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 0] | 10 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 21] | 280 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 0] | 112 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 21] | 350 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 0] | 74 Subjects |
| Thiomersal-free FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 21] | 349 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 0] | 75 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 0] | 6 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 21] | 348 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Solomon Islands [Day 21] | 287 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | B/Malaysia [Day 21] | 351 Subjects |
| Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group | Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains | A/Wisconsin [Day 0] | 97 Subjects |