Influenza
Conditions
Keywords
Immunogenicity, Trivalent, Safety, Adults, Elderly, Influenza
Brief summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults aged 18 years and older.
Interventions
BIOLOGICALFluviral™
1 dose administered intramuscularly in deltoid region of non-dominant arm.
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, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female 18 years of age and older at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy subjects or subjects with well-controlled chronic disease, as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination dose.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. * Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration during the study period. * Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period. * Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period. * Clinically or virologically confirmed influenza infection within the 6 months preceding the study vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required): * History of human immunodeficiency virus (HIV) infection, * Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * Acute disease and/or fever at the time of enrollment. * Acute disease is defined as the presence of a short term, moderate or severe illness, with or without fever. * Fever is defined as temperature ≥ 38.0°C/100.4°F for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. * Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. Uncontrolled is defined as: * Requiring institution of new medical or surgical treatment within one month prior to study enrollment, or * Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or * Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or * Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Subjects who participated in the registration trial \[116664 (FLU Q-TIV-014)\] for Fluviral™ 2012/2013 conducted in the 2012-2013 season. * Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder. * A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period. * Any known or suspected allergy to any constituent of Fluviral™ and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury. * A history of severe adverse reaction to a previous influenza vaccination. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Any condition which, in the opinion of the investigator, prevents the subject from participation in the study or would make the intramuscular injection unsafe.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | At Days 0 and 21 | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). |
| Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | At Day 21 | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | At Day 21 | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | At Days 0 and Day 21 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | During the 4-day (Days 0-3) post-vaccination period | Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | During the 4-day (Days 0-3) post-vaccination period | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever \[oral temperature above 37.5 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C |
| Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | At Days 0 and Day 21 | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | During the entire study period (Days 0-20 post vaccination) | A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | During the 21-day (Days 0-20) post-vaccination period | 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. |
| Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | At Day 21 | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season. |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | At Day 21 | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season. |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | At Day 0 and Day 21 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season. |
Countries
Canada
Participant flow
Pre-assignment details
1 volunteer was assigned a subject number but was subsequently determined to be ineligible for study participation and was never vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluviral 18-60 Years Group Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 60 |
| Fluviral >60 Years Group Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Fluviral 18-60 Years Group | Fluviral >60 Years Group | Total |
|---|---|---|---|
| Age, Continuous | 41.1 Years STANDARD_DEVIATION 11.63 | 68.6 Years STANDARD_DEVIATION 4.92 | 54.9 Years STANDARD_DEVIATION 16.42 |
| Sex: Female, Male Female | 40 Participants | 32 Participants | 72 Participants |
| Sex: Female, Male Male | 20 Participants | 28 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 60 | 23 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Time frame: At Days 0 and 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and 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) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 0 | 61.0 Titer |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 21 | 337.4 Titer |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 0 | 37.3 Titer |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 21 | 159.0 Titer |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 0 | 200.0 Titer |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 21 | 521.1 Titer |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 0 | 159.0 Titer |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 0 | 65.7 Titer |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 21 | 133.7 Titer |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 21 | 207.5 Titer |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 21 | 407.8 Titer |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 0 | 31.5 Titer |
Primary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and 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) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | Yamagata | 2.6 Fold increase |
| Fluviral 18-60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H1N1 | 5.5 Fold increase |
| Fluviral 18-60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H3N2 | 4.3 Fold increase |
| Fluviral >60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | Yamagata | 2.6 Fold increase |
| Fluviral >60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H1N1 | 3.2 Fold increase |
| Fluviral >60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H3N2 | 4.2 Fold increase |
Primary
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1 | 32 Subjects |
| Fluviral 18-60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2 | 24 Subjects |
| Fluviral 18-60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata | 21 Subjects |
| Fluviral >60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1 | 22 Subjects |
| Fluviral >60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2 | 25 Subjects |
| Fluviral >60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata | 17 Subjects |
Primary
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Time frame: At Days 0 and Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 21 | 59 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 0 | 55 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 0 | 41 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 0 | 37 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 21 | 56 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 21 | 59 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 0 | 44 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 21 | 59 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 21 | 60 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 0 | 56 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 21 | 54 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 0 | 33 Subjects |
Secondary
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Time frame: At Days 0 and Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and 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) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 0 | 132.2 Titers |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 21 | 249.0 Titers |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 0 | 58.6 Titers |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 21 | 107.9 Titers |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 0 | 352.1 Titers |
| Fluviral 18-60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 21 | 436.7 Titers |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 21 | 618.2 Titers |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 21 | 231.5 Titers |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 0 | 28.9 Titers |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 0 | 24.1 Titers |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 21 | 452.6 Titers |
| Fluviral >60 Years Group | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 0 | 115.8 Titers |
| Fluviral >60 Years Group With Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 21 | 136.1 Titers |
| Fluviral >60 Years Group With Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 0 | 47.5 Titers |
| Fluviral >60 Years Group With Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 21 | 109.3 Titers |
| Fluviral >60 Years Group With Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 21 | 342.9 Titers |
| Fluviral >60 Years Group With Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 0 | 218.6 Titers |
| Fluviral >60 Years Group With Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 0 | 70.5 Titers |
| Fluviral > 60 Years Group Without Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 0 | 115.7 Titers |
| Fluviral > 60 Years Group Without Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | Yamagata, Day 21 | 485.0 Titers |
| Fluviral > 60 Years Group Without Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 21 | 316.3 Titers |
| Fluviral > 60 Years Group Without Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 21 | 163.6 Titers |
| Fluviral > 60 Years Group Without Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H1N1, Day 0 | 61.3 Titers |
| Fluviral > 60 Years Group Without Vaccination | Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains | H3N2, Day 0 | 20.9 Titers |
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and 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) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H1N1 | 1.9 Fold increase |
| Fluviral 18-60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | Yamagata | 1.2 Fold increase |
| Fluviral 18-60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H3N2 | 1.8 Fold increase |
| Fluviral >60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H1N1 | 15.6 Fold increase |
| Fluviral >60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | Yamagata | 5.3 Fold increase |
| Fluviral >60 Years Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H3N2 | 9.6 Fold increase |
| Fluviral >60 Years Group With Vaccination | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H3N2 | 2.3 Fold increase |
| Fluviral >60 Years Group With Vaccination | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H1N1 | 1.9 Fold increase |
| Fluviral >60 Years Group With Vaccination | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | Yamagata | 1.6 Fold increase |
| Fluviral > 60 Years Group Without Vaccination | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H1N1 | 5.2 Fold increase |
| Fluviral > 60 Years Group Without Vaccination | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | Yamagata | 4.2 Fold increase |
| Fluviral > 60 Years Group Without Vaccination | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. | H3N2 | 7.8 Fold increase |
Secondary
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Time frame: At Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1 | 7 Subjects |
| Fluviral 18-60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata | 2 Subjects |
| Fluviral 18-60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2 | 4 Subjects |
| Fluviral >60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1 | 25 Subjects |
| Fluviral >60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata | 19 Subjects |
| Fluviral >60 Years Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2 | 20 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2 | 7 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1 | 6 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata | 3 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1 | 16 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata | 14 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2 | 18 Subjects |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Induration | 2 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Induration | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 42 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 5 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Induration | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Induration | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 2 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 15 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever \[oral temperature above 37.5 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 18 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms | 4 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 9 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 18 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 2 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 4 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms | 4 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Sweating | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 6 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 4 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever ( ≥ 37.5°C) | 2 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever (>39.0°C) | 0 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 9 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 6 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 6 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 5 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 5 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 6 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 6 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms | 3 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms | 3 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 6 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 2 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 6 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 6 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Sweating | 3 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Sweating | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Sweating | 3 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever ( ≥ 37.5°C) | 1 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever (>39.0°C) | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 1 Subjects |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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.
Time frame: During the entire study period (Days 0-20 post vaccination)
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Subjects |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 21-day (Days 0-20) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluviral 18-60 Years Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 9 Subjects |
| Fluviral >60 Years Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 7 Subjects |
Secondary
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.
Time frame: At Day 0 and Day 21
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 0 | 27 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 21 | 29 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 0 | 22 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 21 | 27 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 0 | 29 Subjects |
| Fluviral 18-60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 21 | 29 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 21 | 30 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 21 | 29 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 0 | 14 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 0 | 15 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 21 | 30 Subjects |
| Fluviral >60 Years Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 0 | 26 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 21 | 29 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 0 | 20 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 21 | 26 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 21 | 30 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 0 | 30 Subjects |
| Fluviral >60 Years Group With Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 0 | 23 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 0 | 26 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | Yamagata, Day 21 | 30 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 21 | 30 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 21 | 28 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H1N1, Day 0 | 21 Subjects |
| Fluviral > 60 Years Group Without Vaccination | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. | H3N2, Day 0 | 13 Subjects |