Influenza
Conditions
Keywords
Flu, Safety, Immunogenicity, Flu vaccine, Influenza, Virus
Brief summary
Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.
Detailed description
This is a study of two different dose levels of a new formulation of flu vaccine for the 2008/2009 flu season using the World Health Organization recommended virus strains. Subjects will be randomly put into one of three different groups to receive either one or two doses of: 0.25 mL dose of the new flu vaccine, or 0.5 mL dose of the new flu vaccine or the licensed Vaxigrip flu vaccine (control) The parents of the subjects and the study doctor and nurses will not know the group of their child until the study is completed. The children will be vaccinated with either one dose or two doses depending on whether or not they have received a flu vaccine before. The doctor will decide on the schedule for each child based on the information provided by the parents. The active phase of the study will last approximately two months for children receiving two doses and one month for those receiving a single dose. An extended safety follow-up will continue until Study Month 6. Two blood samples will be taken from each subject. These will be used to evaluate how well the vaccine works in the children and which dose level works best compared to the control. The parents will fill in a diary card for four days to record any reactions or symptoms which may occur after vaccination. Parents will also keep a record of other symptoms that may occur between vaccinations and up to six months after the first vaccination and will keep a record of any medication their child takes in this time period.
Interventions
BIOLOGICALGSK Biologicals' influenza vaccine GSK1557482A
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
BIOLOGICALVaxigrip
one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
* A male or female child 6 months to \< 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season; * Subjects must be in good health established by medical history and physical examination before entering into the study; * Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study; * Written informed consent obtained from the subject's parent/guardian. * Parents/guardian access to a consistent means of telephone contact, land line or mobile
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion; * History of hypersensitivity to any vaccine; * History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate; * History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine. * Acute disease at the time of enrolment. * History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine; * Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis; * Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period. * Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign. * Any use of analgesics/antipyretics 12 hours before receipt of vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | During the 4-day follow-up period (Days 0-3) after any vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | During the 4-day follow-up period (Days 0-3) after any vaccination | Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | During the 28-day follow-up period (Days 0-27) after vaccination | Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
| Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | During the 28-day post-vaccination period | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | During the 28-day post-vaccination period | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | During the 4-day follow-up period (Days 0-3) after any vaccination | Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | During the 28-day follow-up period (Days 0-27) after vaccination | Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies | At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | During the 28-day post-vaccination period | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
| Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | During the 28-day post-vaccination period after vaccination | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
| Number of Subjects Seroconverted to HI Antibodies | At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST] | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida. |
| Number of Subjects Seroprotected Against HI Antibodies | At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST] | A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida. |
| Seroconversion Factor for HI Antibodies | At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST] | The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0). The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | During the 4-day follow-up period (Days 0-3) after any vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
Countries
Canada
Participant flow
Recruitment details
Subjects were differentiated according to priming status. Primed Subjects - subjects who had a prior 2-dose priming influenza immunization received a 1-dose vaccination course in the study. Unprimed Subjects - subjects who had not previously received a complete 2-dose priming influenza immunization received a 2-dose vaccination course in the study.
Pre-assignment details
Study comprised an Active phase of approximately 2 months and a post-vaccination 180 day extended safety follow-up period (ESFU phase). 374 subjects out of the 390 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria.
Participants by arm
| Arm | Count |
|---|---|
| Fluviral F1 Group Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm. | 164 |
| Fluviral F2 Group Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm. | 167 |
| Vaxigrip Group Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm. | 43 |
| Total | 374 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Active Phase | Adverse Event | 3 | 1 | 0 |
| Active Phase | Lost to Follow-up | 1 | 1 | 0 |
| Active Phase | Other | 2 | 0 | 0 |
| Active Phase | Withdrawal by Subject | 1 | 4 | 0 |
| ESFU Phase | Adverse Event | 2 | 1 | 0 |
| ESFU Phase | Lost to Follow-up | 6 | 7 | 2 |
| ESFU Phase | Other | 2 | 0 | 0 |
| ESFU Phase | Withdrawal by Subject | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | Fluviral F1 Group | Fluviral F2 Group | Vaxigrip Group | Total |
|---|---|---|---|---|
| Age, Continuous | 18.2 Years STANDARD_DEVIATION 9.06 | 17.5 Years STANDARD_DEVIATION 8.27 | 17.0 Years STANDARD_DEVIATION 8.33 | 17.7 Years STANDARD_DEVIATION 8.62 |
| Sex: Female, Male Female | 70 Participants | 83 Participants | 26 Participants | 179 Participants |
| Sex: Female, Male Male | 94 Participants | 84 Participants | 17 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 129 / 164 | 138 / 167 | 34 / 43 |
| serious Total, serious adverse events | 2 / 164 | 2 / 167 | 0 / 43 |
Outcome results
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time frame: During the 4-day follow-up period (Days 0-3) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any pain | 45 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 pain | 1 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any redness | 49 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 redness | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any swelling | 22 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 swelling | 0 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any swelling | 24 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any pain | 55 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 redness | 0 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 pain | 1 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 swelling | 0 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any redness | 54 Participants |
Primary
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time frame: During the 28-day post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Any SAE(s) | 1 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Related SAE(s) | 0 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Any SAE(s) | 1 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Related SAE(s) | 0 Participants |
Primary
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time frame: During the 6-month safety follow up after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Any SAE(s) | 1 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Related SAE(s) | 0 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Any SAE(s) | 1 Participants |
| Fluviral F2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Related SAE(s) | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time frame: During the 6-month safety follow up after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | 73 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | 57 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time frame: During the 28-day post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | 52 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | 40 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time frame: During the 4-day follow-up period (Days 0-3) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any drowsiness | 54 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 drowsiness | 3 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related drowsiness | 44 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any irritability | 81 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 irritability | 9 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related irritability | 62 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any loss of appetite | 50 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 loss of appetite | 5 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related loss of appetite | 37 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any fever | 16 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 fever | 4 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related fever | 10 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 fever | 1 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any drowsiness | 65 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any loss of appetite | 54 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 drowsiness | 3 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any fever | 9 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related drowsiness | 52 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 loss of appetite | 5 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any irritability | 83 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related fever | 6 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 irritability | 7 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related loss of appetite | 43 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related irritability | 69 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time frame: During the 28-day follow-up period (Days 0-27) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Any unsolicited AE(s) | 108 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Grade 3 unsolicited AE(s) | 19 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Related unsolicited AE(s) | 26 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Any unsolicited AE(s) | 112 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Grade 3 unsolicited AE(s) | 17 Participants |
| Fluviral F2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Related unsolicited AE(s) | 30 Participants |
Secondary
Number of Subjects Seroconverted to HI Antibodies
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Time frame: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects Seroconverted to HI Antibodies | A/Uruguay (H3N2) [POST] | 81 Participants |
| Fluviral F1 Group | Number of Subjects Seroconverted to HI Antibodies | A/Brisbane (H1N1) [POST] | 67 Participants |
| Fluviral F1 Group | Number of Subjects Seroconverted to HI Antibodies | B/Florida [POST] | 106 Participants |
| Fluviral F2 Group | Number of Subjects Seroconverted to HI Antibodies | A/Uruguay (H3N2) [POST] | 98 Participants |
| Fluviral F2 Group | Number of Subjects Seroconverted to HI Antibodies | A/Brisbane (H1N1) [POST] | 82 Participants |
| Fluviral F2 Group | Number of Subjects Seroconverted to HI Antibodies | B/Florida [POST] | 114 Participants |
| Vaxigrip Group | Number of Subjects Seroconverted to HI Antibodies | A/Brisbane (H1N1) [POST] | 29 Participants |
| Vaxigrip Group | Number of Subjects Seroconverted to HI Antibodies | B/Florida [POST] | 31 Participants |
| Vaxigrip Group | Number of Subjects Seroconverted to HI Antibodies | A/Uruguay (H3N2) [POST] | 28 Participants |
Secondary
Number of Subjects Seroprotected Against HI Antibodies
A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Brisbane (H1N1) [PRE] | 17 Participants |
| Fluviral F1 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Brisbane (H1N1) [POST] | 70 Participants |
| Fluviral F1 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Uruguay (H3N2) [PRE] | 10 Participants |
| Fluviral F1 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Uruguay (H3N2) [POST] | 82 Participants |
| Fluviral F1 Group | Number of Subjects Seroprotected Against HI Antibodies | B/Florida [PRE] | 17 Participants |
| Fluviral F1 Group | Number of Subjects Seroprotected Against HI Antibodies | B/Florida [POST] | 111 Participants |
| Fluviral F2 Group | Number of Subjects Seroprotected Against HI Antibodies | B/Florida [POST] | 122 Participants |
| Fluviral F2 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Brisbane (H1N1) [PRE] | 21 Participants |
| Fluviral F2 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Uruguay (H3N2) [POST] | 99 Participants |
| Fluviral F2 Group | Number of Subjects Seroprotected Against HI Antibodies | B/Florida [PRE] | 20 Participants |
| Fluviral F2 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Brisbane (H1N1) [POST] | 84 Participants |
| Fluviral F2 Group | Number of Subjects Seroprotected Against HI Antibodies | A/Uruguay (H3N2) [PRE] | 23 Participants |
| Vaxigrip Group | Number of Subjects Seroprotected Against HI Antibodies | A/Brisbane (H1N1) [POST] | 30 Participants |
| Vaxigrip Group | Number of Subjects Seroprotected Against HI Antibodies | A/Uruguay (H3N2) [PRE] | 3 Participants |
| Vaxigrip Group | Number of Subjects Seroprotected Against HI Antibodies | B/Florida [POST] | 33 Participants |
| Vaxigrip Group | Number of Subjects Seroprotected Against HI Antibodies | A/Uruguay (H3N2) [POST] | 30 Participants |
| Vaxigrip Group | Number of Subjects Seroprotected Against HI Antibodies | A/Brisbane (H1N1) [PRE] | 5 Participants |
| Vaxigrip Group | Number of Subjects Seroprotected Against HI Antibodies | B/Florida [PRE] | 7 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time frame: During the 4-day follow-up period (Days 0-3) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any pain | 17 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 pain | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any redness | 13 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 redness | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any swelling | 5 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 swelling | 0 Participants |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time frame: During the 6-month safety follow up after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Any SAE(s) | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time frame: During the 28-day post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Any SAE(s) | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time frame: During the 6-month safety follow up after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | 14 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time frame: During the 28-day post-vaccination period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination | 9 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time frame: During the 4-day follow-up period (Days 0-3) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any drowsiness | 16 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 drowsiness | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related drowsiness | 11 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any irritability | 22 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 irritability | 1 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related irritability | 15 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any loss of appetite | 14 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 loss of appetite | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related loss of appetite | 9 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Any fever | 3 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Grade 3 fever | 0 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination | Related fever | 2 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time frame: During the 28-day follow-up period (Days 0-27) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Any unsolicited AE(s) | 24 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Grade 3 unsolicited AE(s) | 3 Participants |
| Fluviral F1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination | Related unsolicited AE(s) | 8 Participants |
Secondary
Seroconversion Factor for HI Antibodies
The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0). The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Time frame: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and 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 F1 Group | Seroconversion Factor for HI Antibodies | A/Uruguay (H3N2) [POST] | 9.2 fold increase |
| Fluviral F1 Group | Seroconversion Factor for HI Antibodies | A/Brisbane (H1N1) [POST] | 6.8 fold increase |
| Fluviral F1 Group | Seroconversion Factor for HI Antibodies | B/Florida [POST] | 16.2 fold increase |
| Fluviral F2 Group | Seroconversion Factor for HI Antibodies | A/Uruguay (H3N2) [POST] | 9.7 fold increase |
| Fluviral F2 Group | Seroconversion Factor for HI Antibodies | A/Brisbane (H1N1) [POST] | 8.3 fold increase |
| Fluviral F2 Group | Seroconversion Factor for HI Antibodies | B/Florida [POST] | 20.7 fold increase |
| Vaxigrip Group | Seroconversion Factor for HI Antibodies | A/Brisbane (H1N1) [POST] | 14.9 fold increase |
| Vaxigrip Group | Seroconversion Factor for HI Antibodies | B/Florida [POST] | 17.6 fold increase |
| Vaxigrip Group | Seroconversion Factor for HI Antibodies | A/Uruguay (H3N2) [POST] | 13.3 fold increase |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and 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 F1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Brisbane (H1N1) strain [PRE] | 8.3 Titer |
| Fluviral F1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Brisbane (H1N1) strain [POST] | 56.3 Titer |
| Fluviral F1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Uruguay (H3N2) strain [PRE] | 7.0 Titer |
| Fluviral F1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Uruguay (H3N2) strain [POST] | 64.5 Titer |
| Fluviral F1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | B/Florida strain [PRE] | 7.9 Titer |
| Fluviral F1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | B/Florida strain [POST] | 128.7 Titer |
| Fluviral F2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | B/Florida strain [POST] | 163.7 Titer |
| Fluviral F2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Brisbane (H1N1) strain [PRE] | 8.5 Titer |
| Fluviral F2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Uruguay (H3N2) strain [POST] | 89.5 Titer |
| Fluviral F2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | B/Florida strain [PRE] | 7.9 Titer |
| Fluviral F2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Brisbane (H1N1) strain [POST] | 70.7 Titer |
| Fluviral F2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Uruguay (H3N2) strain [PRE] | 9.2 Titer |
| Vaxigrip Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Brisbane (H1N1) strain [POST] | 120.9 Titer |
| Vaxigrip Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Uruguay (H3N2) strain [PRE] | 7.3 Titer |
| Vaxigrip Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | B/Florida strain [POST] | 190.3 Titer |
| Vaxigrip Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Uruguay (H3N2) strain [POST] | 97.8 Titer |
| Vaxigrip Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | A/Brisbane (H1N1) strain [PRE] | 8.1 Titer |
| Vaxigrip Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies | B/Florida strain [PRE] | 10.8 Titer |