Influenza
Conditions
Keywords
GSK Biologicals influenza vaccine GSK1557482A, influenza infection
Brief summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
Interventions
BIOLOGICALGSK investigational vaccine GSK1557482A
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
BIOLOGICALFluzone®
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol. * A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable. * Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and history-directed clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * 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 series.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion. * Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season. * Child in care * Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * History of hypersensitivity to any vaccine. * History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Acute disease and/or fever at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). |
| Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | At Day 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. |
| Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | At Day 0 and at Day 28 after last vaccine dose | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. |
| Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and at Day 28 after last vaccine dose | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination. |
| Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination. |
| Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | During a 4-day follow-up period (Days 0-3) after vaccination. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | During a 28 day follow-up period (Days 0-27) after vaccination. | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | During a 28 day follow-up period (Days 0-27) after vaccination. | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Medically Attended Adverse Events (MAEs). | During the entire study period (From Day 0 up to Day 180). | For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | During the entire study period (From Day 0 up to Day 180). | An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
| Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
Countries
United States
Participant flow
Pre-assignment details
Subjects were stratified by age-strata: 3-4, 5-8 and 9-17 years and received vaccine according to their priming status: primed subjects received a 2-dose priming immunization in a previous season, whereas unprimed subjects had not. Blood samples: at Days 0 - 28 for primed subjects and subjects 9-17 years and at Days 0-56 for unprimed subjects.
Participants by arm
| Arm | Count |
|---|---|
| Flulaval Group subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | 1,055 |
| Fluzone Group subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. | 1,061 |
| Total | 2,116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 37 | 43 |
| Overall Study | Other | 4 | 3 |
| Overall Study | Withdrawal by Subject | 6 | 17 |
Baseline characteristics
| Characteristic | Flulaval Group | Fluzone Group | Total |
|---|---|---|---|
| Age, Continuous | 7.8 Years STANDARD_DEVIATION 4.18 | 7.8 Years STANDARD_DEVIATION 4.1 | 7.8 Years STANDARD_DEVIATION 4.14 |
| Sex: Female, Male Female | 500 Participants | 496 Participants | 996 Participants |
| Sex: Female, Male Male | 555 Participants | 565 Participants | 1120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 742 / 1,055 | 710 / 1,061 |
| serious Total, serious adverse events | 10 / 1,055 | 6 / 1,061 |
Outcome results
Primary
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Time frame: At Day 0 and 28 after last vaccine dose.
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 28] | 320.9 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 28] | 414.7 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 0] | 16.6 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 0] | 46.0 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 28] | 213.7 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 0] | 57.1 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 28] | 200.2 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 0] | 45.8 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 28] | 329.4 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 0] | 63.9 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 0] | 16.8 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 28] | 451.9 Titers |
Primary
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Time frame: At Day 28 after last vaccine dose.
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | A/Brisbane | 590 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | A/Uruguay | 673 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | B/Brisbane | 800 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | A/Brisbane | 569 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | A/Uruguay | 647 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | B/Brisbane | 769 Participants |
Secondary
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Time frame: At Day 0 and 28 after last vaccine dose.
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [9-17 years] | 60.2 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [5-8 years] | 476.3 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [5-8 years] | 40.2 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [9-17 years] | 56.3 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [9-17 years] | 473.6 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [9-17 years] | 438.4 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [3-4 years] | 263.5 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [3-4 years] | 13.1 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [3-4 years] | 174.1 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [3-4 years] | 38.7 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [5-8 years] | 16.2 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [5-8 years] | 251.8 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [5-8 years] | 196.8 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [3-4 years] | 322.8 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [9-17 years] | 20.5 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [3-4 years] | 38.4 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [9-17 years] | 271.1 Titers |
| Flulaval Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [5-8 years] | 78.5 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [9-17 years] | 244.6 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [3-4 years] | 34.4 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [3-4 years] | 281.9 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [5-8 years] | 41.4 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [5-8 years] | 251.5 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [9-17 years] | 61.9 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [9-17 years] | 478.2 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [3-4 years] | 50.2 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [3-4 years] | 418.3 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [5-8 years] | 78.1 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [5-8 years] | 494.2 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [9-17 years] | 62.6 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [9-17 years] | 437.8 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [3-4 years] | 148.5 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [5-8 years] | 16.9 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [5-8 years] | 202.8 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [9-17 years] | 21.7 Titers |
| Fluzone Group | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [3-4 years] | 11.6 Titers |
Secondary
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Time frame: At Day 28 after last vaccine dose.
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [5-8 years] | 211 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [9-17 years] | 237 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [3-4 years] | 203 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [3-4 years] | 227 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [9-17 years] | 218 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [5-8 years] | 289 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [5-8 years] | 233 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [9-17 years] | 284 Participants |
| Flulaval Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [3-4 years] | 161 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [9-17 years] | 262 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [3-4 years] | 177 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [5-8 years] | 191 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [9-17 years] | 201 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [3-4 years] | 190 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [5-8 years] | 228 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [9-17 years] | 229 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [3-4 years] | 214 Participants |
| Fluzone Group | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [5-8 years] | 293 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
Time frame: At Day 0 and 28 after last vaccine dose.
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 0] | 640 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 28] | 969 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 0] | 676 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 28] | 970 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 0] | 359 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 28] | 936 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 0] | 360 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 0] | 639 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 28] | 973 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Brisbane [at Day 28] | 965 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | B/Brisbane [at Day 28] | 925 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | A/Uruguay [at Day 0] | 690 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Time frame: At Day 0 and 28 after last vaccine dose.
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [3-4 years] | 265 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [3-4 years] | 265 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [3-4 years] | 80 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [5-8 years] | 227 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [5-8 years] | 127 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [5-8 years] | 347 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [5-8 years] | 349 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [9-17 years] | 258 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [5-8 years] | 334 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [9-17 years] | 357 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [5-8 years] | 267 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [9-17 years] | 256 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [3-4 years] | 153 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [9-17 years] | 152 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [3-4 years] | 254 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [9-17 years] ) | 356 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [9-17 years] | 348 Participants |
| Flulaval Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [3-4 years] | 155 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [9-17 years] | 351 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [3-4 years] | 158 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [3-4 years] | 259 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [5-8 years] | 269 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [5-8 years] | 351 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 28 [9-17 years] ) | 363 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [5-8 years] | 127 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [5-8 years] | 335 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [9-17 years] | 165 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [3-4 years] | 145 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [3-4 years] | 258 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [5-8 years] | 228 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [5-8 years] | 346 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 0 [9-17 years] | 266 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay at Day 0 [9-17 years] | 263 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 0 [3-4 years] | 68 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane at Day 28 [3-4 years] | 239 Participants |
| Fluzone Group | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane at Day 28 [9-17 years] | 361 Participants |
Secondary
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Irritability related to vaccination | 81 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any loss of appetite | 52 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any drowsiness | 61 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 7 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Drowsiness related to vaccination | 57 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Loss of appetite related to vaccination | 45 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any irritability | 86 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 38.0°C | 15 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 39.0°C - <= 40.0°C | 3 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 irritability | 6 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever related to vaccination | 14 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 4 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever related to vaccination | 8 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Irritability related to vaccination | 81 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any drowsiness | 63 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 2 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any irritability | 87 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 irritability | 4 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any loss of appetite | 47 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 2 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Loss of appetite related to vaccination | 42 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 38.0°C | 10 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 39.0°C - <= 40.0°C | 2 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Drowsiness related to vaccination | 56 Participants |
Secondary
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination.
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any muscle aches | 200 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any fatigue | 138 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Shivering related to vaccination | 36 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 fatigue | 11 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 38.0°C | 36 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fatigue related to vaccination | 119 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Muscle aches related to vaccination | 180 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any headache | 141 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 39.0°C - <= 40.0°C | 12 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 headache | 6 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any shivering | 45 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any arthralgia | 70 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 muscle aches | 6 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Headache related to vaccination | 115 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 shivering | 2 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Arthralgia related to vaccination | 65 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Temperature related to vaccination | 27 Participants |
| Flulaval Less Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 arthralgia | 2 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Temperature related to vaccination | 25 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Headache related to vaccination | 105 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any shivering | 40 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 shivering | 3 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 38.0°C | 36 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fever >= 39.0°C - <= 40.0°C | 13 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any arthralgia | 80 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 arthralgia | 2 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Arthralgia related to vaccination | 74 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any fatigue | 137 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 fatigue | 10 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Fatigue related to vaccination | 117 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any headache | 131 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 headache | 4 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Any muscle aches | 189 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Grade 3 muscle aches | 7 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Muscle aches related to vaccination | 179 Participants |
| Fluzone Les Than 5 Years Old Group | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | Shivering related to vaccination | 31 Participants |
Secondary
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 swelling | 1 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 26 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 57 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 51 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 redness | 2 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 615 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 59 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 28 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 redness | 1 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 swelling | 0 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 584 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 53 Participants |
Secondary
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 swelling [9-17 years] | 0 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 pain [3-4 years] | 5 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 swelling [3-4 years] | 0 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any pain [5-8 years] | 252 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 pain [5-8 years] | 16 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any pain [9-17 years] | 224 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 pain [9-17 years] | 5 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any redness [9-17 years] | 13 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any swelling [9-17 years] | 18 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any redness [3-4 years] | 14 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 redness [3-4 years] | 0 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any swelling [3-4 years] | 9 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any redness [5-8 years] | 30 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 redness [5-8 years] | 2 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any swelling [5-8 years] | 24 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 swelling [5-8 years] | 1 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 redness [9-17 years] | 0 Participants |
| Flulaval Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any pain [3-4 years] | 139 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 redness [5-8 years] | 1 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any redness [3-4 years] | 18 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any swelling [3-4 years] | 11 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any redness [9-17 years] | 13 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 redness [3-4 years] | 0 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any pain [5-8 years] | 249 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any swelling [5-8 years] | 28 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 pain [5-8 years] | 18 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 swelling [3-4 years] | 0 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any pain [9-17 years] | 205 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 redness [9-17 years] | 0 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 pain [9-17 years] | 6 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any redness [5-8 years] | 22 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 swelling [5-8 years] | 0 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any swelling [9-17 years] | 20 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 swelling [9-17 years] | 0 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Any pain [3-4 years] | 130 Participants |
| Fluzone Group | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Grade 3 pain [3-4 years] | 4 Participants |
Secondary
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time frame: During a 28 day follow-up period (Days 0-27) after vaccination.
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Any AE(s) | 421 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Grade 3 AE(s) | 81 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Related AE(s) | 65 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Any AE(s) | 387 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Grade 3 AE(s) | 83 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Related AE(s) | 57 Participants |
Secondary
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time frame: During a 28 day follow-up period (Days 0-27) after vaccination.
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Related AE(s) [3-4 years] | 17 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Related AE(s) [5-8 years] | 32 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Grade 3 AE(s) [3-4 years] | 23 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any AE(s) [9-17 years] | 112 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any AE(s) [5-8 years] | 175 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Grade 3 AE(s) [9-17 years] | 22 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any AE(s) [3-4 years] | 134 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Related AE(s) [9-17 years] | 16 Participants |
| Flulaval Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Grade 3 AE(s) [5-8 years] | 36 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Related AE(s) [9-17 years] | 17 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Grade 3 AE(s) [3-4 years] | 25 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Related AE(s) [3-4 years] | 16 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any AE(s) [5-8 years] | 149 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Grade 3 AE(s) [5-8 years] | 32 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Related AE(s) [5-8 years] | 24 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any AE(s) [9-17 years] | 110 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Grade 3 AE(s) [9-17 years] | 26 Participants |
| Fluzone Group | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any AE(s) [3-4 years] | 128 Participants |
Secondary
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Time frame: During the entire study period (From Day 0 up to Day 180).
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flulaval Group | Number of Subjects Reporting Medically Attended Adverse Events (MAEs). | 447 Participants |
| Fluzone Group | Number of Subjects Reporting Medically Attended Adverse Events (MAEs). | 432 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs).
An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time frame: During the entire study period (From Day 0 up to Day 180).
Population: The Total Vaccinated cohort included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Flulaval Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 10 Participants |
| Fluzone Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 6 Participants |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
Time frame: At Day 0 and at Day 28 after last vaccine dose
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | A/Brisbane | 7.0 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | A/Uruguay | 7.3 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | B/Brisbane | 12.8 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | A/Brisbane | 7.2 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | A/Uruguay | 7.1 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | B/Brisbane | 11.9 Fold change |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Time frame: At Day 0 and at Day 28 after last vaccine dose
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [3-4 years] | 6.9 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [5-8 years] | 6.1 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [9-17 years] | 13.2 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [5-8 years] | 6.3 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [9-17 years] | 7.9 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [3-4 years] | 8.4 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [9-17 years] | 7.8 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [3-4 years] | 13.3 Fold change |
| Flulaval Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [5-8 years] | 12.2 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [9-17 years] | 11.3 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [3-4 years] | 8.2 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [3-4 years] | 8.3 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [5-8 years] | 12.0 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [5-8 years] | 6.3 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | B/Brisbane [3-4 years] | 12.8 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [5-8 years] | 6.1 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Uruguay [9-17 years] | 7.0 Fold change |
| Fluzone Group | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | A/Brisbane [9-17 years] | 7.7 Fold change |