Influenza
Conditions
Keywords
Fluzone Quadrivalent, Comparator, Children, Seasonal influenza, Safety, Immunogenicity
Brief summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.
Interventions
BIOLOGICALFluLaval™ Quadrivalent
1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively
BIOLOGICALFluzone® Quadrivalent
1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 35 months of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history. * Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted. * Child in care. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean a dose equivalent to either \> 2 mg/kg/day of body weight, or to ≥ 20 mg/day of prednisone for persons who weigh ≥ 10 kg, when administered for more than 2 weeks. Inhaled and topical steroids are allowed. * Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within six months preceding the first dose of study vaccine, or planned use during the study period. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine. * Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 38.0°C/100.4°F by any route. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees 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 vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria). |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During a 7-day (Day 0 - Day 6) follow-up period after each vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the 7-day (Days 0-6) follow-up period after each vaccination | Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C. |
| Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the 7-day (Days 0-6) follow-up period after each vaccination. | Duration was defined as number of days with any grade of local and general symptoms. |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | During the entire study period (Days 0 -180) | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). |
| Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the entire study period (Days 0 -180) | pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the entire study period (Days 0 -180) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | During a 2-day (Days 0-1) follow-up period after each vaccination | Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature \< 38.0°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C. |
| Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
Countries
Mexico, United States
Participant flow
Recruitment details
Primed subjects:Received atleast 2 doses of seasonal influenza vaccine since 1 July 2010 or atleast 1 dose of the 2013-2014 seasonal influenza vaccine. Unprimed subjects:Did not receive any seasonal influenza vaccine or received only 1 dose of seasonal influenza vaccine since 1 July 2010, but did not receive any 2013-2014 seasonal influenza vaccine
Pre-assignment details
Data has been analyzed in sub-groups by age: 6-17 months and 18-35 months and by priming status. 6 subjects were allocated subject numbers but did not receive the study vaccine dose and for 2 subjects the blood samples were withdrawn but they did not participate in the study due to screening failure.
Participants by arm
| Arm | Count |
|---|---|
| FluLaval™ Quadrivalent Group Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age). | 1,207 |
| Fluzone® Quadrivalent Group Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age). | 1,217 |
| Total | 2,424 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Child placed in foster care by family | 0 | 1 |
| Overall Study | Consent withdrawal by parent | 1 | 0 |
| Overall Study | Language barrier | 1 | 0 |
| Overall Study | Lost to Follow-up | 54 | 61 |
| Overall Study | Migrated/moved from study area | 1 | 3 |
| Overall Study | Non-compliance | 1 | 0 |
| Overall Study | Protocol requirements not followed | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 15 | 10 |
| Overall Study | Withdrawal by subject at Visit 2 | 0 | 1 |
Baseline characteristics
| Characteristic | FluLaval™ Quadrivalent Group | Fluzone® Quadrivalent Group | Total |
|---|---|---|---|
| Age, Continuous | 19.4 Months STANDARD_DEVIATION 8.7 | 19.5 Months STANDARD_DEVIATION 8.9 | 19.45 Months STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 547 Participants | 582 Participants | 1129 Participants |
| Sex: Female, Male Male | 660 Participants | 635 Participants | 1295 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 932 / 1,207 | 895 / 1,217 |
| serious Total, serious adverse events | 5 / 1,207 | 4 / 1,217 |
Outcome results
Primary
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains
Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees 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 vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
Time frame: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | H1N1 [N=972,980] | 716 Subjects |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | H3N2 [N=972,980] | 740 Subjects |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Victoria [N=973,980] | 631 Subjects |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Yamagata [N=974,980] | 833 Subjects |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Yamagata [N=974,980] | 723 Subjects |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | H1N1 [N=972,980] | 660 Subjects |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Victoria [N=973,980] | 475 Subjects |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | H3N2 [N=972,980] | 680 Subjects |
95% CI: [-10.34, -2.27]
95% CI: [-10.68, -2.8]
95% CI: [-20.68, -12.02]
95% CI: [-15.28, -8.21]
Primary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Time frame: At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H1N1 | 98.8 Titers |
| FluLaval™ Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H3N2 | 97.7 Titers |
| FluLaval™ Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Yamagata | 257.5 Titers |
| FluLaval™ Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Victoria | 55.1 Titers |
| Fluzone® Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Victoria | 33.4 Titers |
| Fluzone® Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H1N1 | 84.4 Titers |
| Fluzone® Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Yamagata | 164.2 Titers |
| Fluzone® Quadrivalent Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H3N2 | 84.3 Titers |
95% CI: [0.77, 0.95]
95% CI: [0.77, 0.94]
95% CI: [0.59, 0.71]
95% CI: [0.56, 0.69]
Secondary
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Duration was defined as number of days with any grade of local and general symptoms.
Time frame: During the 7-day (Days 0-6) follow-up period after each vaccination.
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 6-17M, Dose 2 [N=129,142] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 18-35M, Dose 1 [N=13,13] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Dose 1 [N=15,15] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 6-17M, Dose 2 [N=1,0] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 18-35M, Dose 2 [N=28,24] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 18-35M, Dose 2 [N=0,2] | 0.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Dose 2 [N=157,166] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, 6-17M, Dose 1 [N=4,0] | 1.5 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 6-17M, Dose 1 [N=273,252] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, 18-35M, Dose 1 [N=7,5] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Dose 2 [N=1,2] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 6-17M, Dose 1 [N=80,70] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 18-35M, Dose 1 [N=297,275] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 18-35M, Dose 1 [N=66,77] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Dose 2 [N=110,116] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 6-17M, Dose 2 [N=47,38] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 6-17M, Dose 2 [N=168,177] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 18-35M, Dose 2 [N=13,10] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, Dose 1 [N=11,5] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Unprimed, Dose 1 [N=212,211] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 18-35M, Dose 2 [N=43,37] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Primed, Dose 1 [N=212,213] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Dose 2 [N=211,214] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Unprimed, Dose 2 [N=157,166] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 6-17M, Dose 1 [N=141,131] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Unprimed, Dose 1 [N=274,256] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Dose 1 [N=146,147] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Primed, Dose 1 [N=296,271] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 18-35M, Dose 1 [N=193,197] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Unprimed, Dose 2 [N=211,214] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Dose 1 [N=464,429] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Unprimed, Dose 1 [N=154,138] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 6-17M, Dose 2 [N=90,91] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Primed, Dose 1 [N=180,190] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Dose 2 [N=60,48] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Unprimed, Dose 2 [N=110,116] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 18-35M, Dose 2 [N=20,25] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Unprimed, Dose 1 [N=187,190] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Dose 1 [N=570, 527] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Primed, Dose 1 [N=277,239] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 6-17M, Dose 1 [N=175,173] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Unprimed, Dose 2 [N=138,147] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 6-17M, Dose 1 [N=200,210] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Unprimed, Dose 1 [N=2,2] | 1.5 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 18-35M, Dose 1 [N=289,256] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Primed, Dose 1 [N=13,13] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Dose 2 [N=138,147] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Unprimed, Dose 2 [N=1,2] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 6-17M, Dose 2 [N=103,108] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, Unprimed, Dose 1 [N=4,0] | 1.5 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 18-35M, Dose 1 [N=224,214] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, Primed, Dose 1 [N=7,5] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 18-35M, Dose 2 [N=35,39] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Unprimed, Dose 1 [N=80,69] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Dose 1 [N=334, 328] | 2.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Primed, Dose 1 [N=66,78] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 6-17M, Dose 1 [N=2,2] | 1.5 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Unprimed, Dose 2 [N=60,48] | 1.0 Days |
| FluLaval™ Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Dose 1 [N=424,424] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Unprimed, Dose 2 [N=60,48] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Dose 1 [N=424,424] | 1.5 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Dose 2 [N=157,166] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Dose 1 [N=570, 527] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Dose 2 [N=211,214] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Dose 1 [N=334, 328] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Dose 2 [N=110,116] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Dose 1 [N=464,429] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Dose 2 [N=138,147] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Dose 1 [N=15,15] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Dose 2 [N=1,2] | 1.5 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, Dose 1 [N=11,5] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Dose 1 [N=146,147] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Dose 2 [N=60,48] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 6-17M, Dose 1 [N=200,210] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 18-35M, Dose 1 [N=224,214] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 6-17M, Dose 2 [N=129,142] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, 18-35M, Dose 2 [N=28,24] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 6-17M, Dose 1 [N=273,252] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 18-35M, Dose 1 [N=297,275] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 6-17M, Dose 2 [N=168,177] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, 18-35M, Dose 2 [N=43,37] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 6-17M, Dose 1 [N=141,131] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 18-35M, Dose 1 [N=193,197] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 6-17M, Dose 2 [N=90,91] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, 18-35M, Dose 2 [N=20,25] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 6-17M, Dose 1 [N=175,173] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 18-35M, Dose 1 [N=289,256] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 6-17M, Dose 2 [N=103,108] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, 18-35M, Dose 2 [N=35,39] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 6-17M, Dose 1 [N=2,2] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 18-35M, Dose 1 [N=13,13] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 6-17M, Dose 2 [N=1,0] | 0.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, 18-35M, Dose 2 [N=0,2] | 1.5 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, 6-17M, Dose 1 [N=4,0] | 0.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, 18-35M, Dose 1 [N=7,5] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 6-17M, Dose 1 [N=80,70] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 18-35M, Dose 1 [N=66,77] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 6-17M, Dose 2 [N=47,38] | 1.5 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, 18-35M, Dose 2 [N=13,10] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Unprimed, Dose 1 [N=212,211] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Primed, Dose 1 [N=212,213] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Drowsiness, Unprimed, Dose 2 [N=157,166] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Unprimed, Dose 1 [N=274,256] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Primed, Dose 1 [N=296,271] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Irritability, Unprimed, Dose 2 [N=211,214] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Unprimed, Dose 1 [N=154,138] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Primed, Dose 1 [N=180,190] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Loss of Appetite, Unprimed, Dose 2 [N=110,116] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Unprimed, Dose 1 [N=187,190] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Primed, Dose 1 [N=277,239] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Pain, Unprimed, Dose 2 [N=138,147] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Unprimed, Dose 1 [N=2,2] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Primed, Dose 1 [N=13,13] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Redness, Unprimed, Dose 2 [N=1,2] | 1.5 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, Unprimed, Dose 1 [N=4,0] | 0.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Swelling, Primed, Dose 1 [N=7,5] | 2.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Unprimed, Dose 1 [N=80,69] | 1.0 Days |
| Fluzone® Quadrivalent Group | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever, Primed, Dose 1 [N=66,78] | 1.0 Days |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 0 | 14.5 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 28/Day 56 | 98.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 0 | 9.2 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 28/Day 56 | 97.7 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 0 | 20.3 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 28/Day 56 | 257.5 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 0 | 6.2 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 28/Day 56 | 55.1 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 0 | 7.2 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 28/Day 56 | 42.7 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 0 | 11.0 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 28/Day 56 | 170.9 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 0 | 5.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 28/Day 56 | 58.9 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 0 | 12.3 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 28/Day 56 | 136.0 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 0 | 12.2 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 28/Day 56 | 151.0 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 0 | 28.0 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 28/Day 56 | 364.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 0 | 5.5 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 28/Day 56 | 68.7 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 0 | 6.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 28/Day 56 | 47.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 0 | 7.5 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 56 | 51.4 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 0 | 14.4 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 28 | 158.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 0 | 6.4 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 56 | 75.0 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 0 | 11.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 28 | 118.4 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 0 | 11.4 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 56 | 179.8 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 0 | 30.5 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 28 | 334.3 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 0 | 5.6 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 56 | 91.7 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 0 | 6.7 Titers |
| FluLaval™ Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 28 | 38.1 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 56 | 44.8 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 0 | 11.1 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 0 | 5.6 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 28/Day 56 | 84.4 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 0 | 12.2 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 0 | 9.6 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 28/Day 56 | 31.9 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 28/Day 56 | 84.3 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 28 | 242.2 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 0 | 20.6 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 0 | 6.8 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 28/Day 56 | 164.2 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 28 | 90.4 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 0 | 6.3 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 28/Day 56 | 34.4 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 28/Day 56 | 33.4 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 28 | 26.7 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 0 | 7.1 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 0 | 8.2 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 28/Day 56 | 43.2 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 0 | 12.4 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 0 | 14.6 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 56 | 56.0 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 28/Day 56 | 129.6 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 0 | 5.6 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 0 | 6.2 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 0 | 13.8 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 28/Day 56 | 54.8 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 56 | 98.1 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 0 | 12.5 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 28 | 115.0 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 28/Day 56 | 111.1 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 0 | 6.8 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 0 | 13.0 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 0 | 6.9 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 28/Day 56 | 79.1 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 0 | 30.1 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 0 | 27.4 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 56 | 76.8 Titers |
| Fluzone® Quadrivalent Group | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 28/Day 56 | 262.1 Titers |
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Time frame: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
Population: The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1 [N=972,980] | 9.0 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2 [N=972,980] | 10.7 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata [N=974,980] | 12.7 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria [N=973,980] | 8.7 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M [N=376,375] | 6.0 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M [N=596,605] | 11.7 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M [N=376,375] | 10.2 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M [N=596,605] | 11.1 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M [N=376,375] | 12.3 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M [N=598,605] | 12.9 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M [N=376,375] | 12.3 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M [N=597,605] | 7.0 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed [N=402,417] | 6.9 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed [N=570, 563] | 10.9 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed [N=402,417] | 11.8 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed [N=570, 563] | 10.0 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed [N=402,417] | 16.0 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed [N=572, 563] | 10.7 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed [N=402,417] | 16.2 Fold increase |
| FluLaval™ Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed [N=571, 563] | 5.6 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed [N=572, 563] | 8.2 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1 [N=972,980] | 7.7 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M [N=376,375] | 5.7 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2 [N=972,980] | 8.9 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed [N=570, 563] | 7.6 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata [N=974,980] | 8.1 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M [N=597,605] | 5.2 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria [N=973,980] | 5.4 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed [N=571, 563] | 4.0 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M [N=376,375] | 6.1 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed [N=402,417] | 6.8 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M [N=596,605] | 8.9 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed [N=402,417] | 8.0 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M [N=376,375] | 8.8 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed [N=570, 563] | 8.5 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M [N=596,605] | 9.0 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed [N=402,417] | 8.0 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M [N=376,375] | 6.1 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed [N=402,417] | 11.2 Fold increase |
| Fluzone® Quadrivalent Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M [N=598,605] | 9.7 Fold increase |
Secondary
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Time frame: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1 [N=972,980] | 716 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2 [N=972,980] | 740 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata [N=974,980] | 833 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria [N=973,980] | 631 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M [N=376,375] | 220 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M [N=596,605] | 496 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M [N=376,375] | 260 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M [N=596,605] | 480 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M [N=376,375] | 299 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M [N=598,605] | 534 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M [N=376,375] | 291 Subjects |
| FluLaval™ Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M [N=597,605] | 340 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M [N=376,375] | 189 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1 [N=972,980] | 660 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M [N=376,375] | 250 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2 [N=972,980] | 680 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M [N=598,605] | 491 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata [N=974,980] | 723 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M [N=596,605] | 430 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria [N=973,980] | 475 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M [N=597,605] | 286 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M [N=376,375] | 216 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M [N=376,375] | 232 Subjects |
| Fluzone® Quadrivalent Group | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M [N=596,605] | 444 Subjects |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Time frame: During a 7-day (Day 0 - Day 6) follow-up period after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 6-17M, Across Doses [N=481,469] | 211 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Dose 2 [N=490,493] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 6-17M, Across Doses [N=481,469] | 15 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 6-17M, Dose 1 [N=478,465] | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 6-17M, Across Doses [N=481,469] | 3 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Dose 2 [N=490,493] | 138 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 6-17M, Across Doses [N=481,469] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 6-17M, Dose 1 [N=478,465] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 6-17M, Across Doses [N=481,469] | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Across doses [N=1156,1151] | 509 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 6-17M, Across Doses [N=481,469] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 18-35M, Dose 1 [N=673,681] | 289 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 18-35M, Across Doses [N=675,682] | 298 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Dose 1 [N=1151,1146] | 15 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 18-35M, Across Doses [N=675,682] | 19 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 18-35M, Dose 1 [N=673,681] | 17 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 18-35M, Across Doses [N=675,682] | 13 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Across doses [N=1156,1151] | 34 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 18-35M, Across Doses [N=675,682] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 18-35M, Dose 1 [N=673,681] | 13 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 18-35M, Across Doses [N=675,682] | 7 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Dose 2 [N=490,493] | 9 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 18-35M, Across Doses [N=675,682] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 18-35M, Dose 1 [N=673,681] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Unprimed, Dose 1 [N=518,516] | 187 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Across doses [N=1156,1151] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Unprimed, Dose 1 [N=518,516] | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 18-35M, Dose 1 [N=673,681] | 7 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Unprimed, Dose 1 [N=518,516] | 2 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Dose 1 [N=1151,1146] | 11 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Unprimed, Dose 1 [N=518,516] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 18-35M, Dose 1 [N=673,681] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Unprimed, Dose 1 [N=518,516 | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Across doses [N=1156,1151] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Unprimed, Dose 1 [N=518,516] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 6-17M, Dose 2 [N=373,372] | 103 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Primed, Dose 1 [N=633,630] | 277 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Dose 2 [N=490,493] | 1 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Primed, Dose 1 [N=633,630] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 6-17M, Dose 2 [N=373,372] | 6 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Primed, Dose 1 [N=633,630] | 13 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Across doses [N=1156,1151] | 11 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Primed, Dose 1 [N=633,630] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 6-17M, Dose 2 [N=373,372] | 1 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Primed, Dose 1 [N=633,630] | 7 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Dose 1 [N=1151,1146] | 28 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Primed, Dose 1 [N=633,630] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 6-17M, Dose 2 [N=373,372] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Unprimed, Dose 2 [N=490,493] | 138 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Across doses [N=1156,1151] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Unprimed, Dose 2 [N=490,493] | 9 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 6-17M, Dose 2 [N=373,372] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Unprimed, Dose 2 [N=490,493] | 1 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Dose 2 [N=490,493] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Unprimed, Dose 2 [N=490,493] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 6-17M, Dose 2 [N=373,372] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Unprimed, Dose 2 [N=490,493] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 6-17M, Dose 1 [N=478,465] | 175 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Unprimed, Dose 2 [N=490,493] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 18-35M, Dose 2 [N=117,121] | 35 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Unprimed, Across Doses [N=523,521] | 232 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Dose 1 [N=1151,1146] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Unprimed, Across Doses [N=523,521] | 18 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 18-35M, Dose 2 [N=117,121] | 3 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Unprimed, Across Doses [N=523,521] | 3 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 6-17M, Dose 1 [N=478,465] | 11 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Unprimed, Across Doses[N=523,521] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Unprimed, Across Doses [N=523,521] | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Dose 2 [N=490,493] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling,Unprimed, Across Doses[N=523,521] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Primed, Across Doses [N=633,630] | 277 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 6-17M, Dose 1 [N=478,465] | 2 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Primed, Across Doses [N=633,630] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Primed, Across Doses [N=633,630] | 13 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Dose 1 [N=1151,1146] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Primed, Across Doses [N=633,630] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Sweling, Primed, Across Doses [N=633,630] | 7 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 6-17M, Dose 1 [N=478,465] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Primed, Across Doses [N=633,630] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Dose 1 [N=1151,1146] | 464 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Primed, Across Doses [N=633,630] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Dose 1 [N=1151,1146] | 429 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Dose 1 [N=1151,1146] | 16 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Dose 1 [N=1151,1146] | 15 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Dose 1 [N=1151,1146] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Dose 1 [N=1151,1146] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Dose 1 [N=1151,1146] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Dose 2 [N=490,493] | 147 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Dose 2 [N=490,493] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Dose 2 [N=490,493] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Dose 2 [N=490,493] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Dose 2 [N=490,493] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Dose 2 [N=490,493] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Across doses [N=1156,1151] | 462 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Across doses [N=1156,1151] | 19 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Across doses [N=1156,1151] | 16 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Across doses [N=1156,1151] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Across doses [N=1156,1151] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Across doses [N=1156,1151] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 6-17M, Dose 1 [N=478,465] | 173 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 6-17M, Dose 1 [N=478,465] | 12 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 6-17M, Dose 1 [N=478,465] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 6-17M, Dose 1 [N=478,465] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 6-17M, Dose 1 [N=478,465] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 6-17M, Dose 1 [N=478,465] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 18-35M, Dose 1 [N=673,681] | 256 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 18-35M, Dose 1 [N=673,681] | 4 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 18-35M, Dose 1 [N=673,681] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 18-35M, Dose 1 [N=673,681] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 18-35M, Dose 1 [N=673,681] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 18-35M, Dose 1 [N=673,681] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 6-17M, Dose 2 [N=373,372] | 108 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 6-17M, Dose 2 [N=373,372] | 1 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 6-17M, Dose 2 [N=373,372] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 6-17M, Dose 2 [N=373,372] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 6-17M, Dose 2 [N=373,372] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 6-17M, Dose 2 [N=373,372] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 18-35M, Dose 2 [N=117,121] | 39 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 18-35M, Dose 2 [N=117,121] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 18-35M, Dose 2 [N=117,121] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 6-17M, Across Doses [N=481,469] | 196 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 6-17M, Across Doses [N=481,469] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 6-17M, Across Doses [N=481,469] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 6-17M, Across Doses [N=481,469] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 6-17M, Across Doses [N=481,469] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 6-17M, Across Doses [N=481,469] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, 18-35M, Across Doses [N=675,682] | 266 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, 18-35M, Across Doses [N=675,682] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, 18-35M, Across Doses [N=675,682] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, 18-35M, Across Doses [N=675,682] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, 18-35M, Across Doses [N=675,682] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, 18-35M, Across Doses [N=675,682] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Unprimed, Dose 1 [N=518,516] | 190 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Unprimed, Dose 1 [N=518,516] | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Unprimed, Dose 1 [N=518,516] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Unprimed, Dose 1 [N=518,516] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Unprimed, Dose 1 [N=518,516 | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Unprimed, Dose 1 [N=518,516] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Primed, Dose 1 [N=633,630] | 239 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Primed, Dose 1 [N=633,630] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Primed, Dose 1 [N=633,630] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Primed, Dose 1 [N=633,630] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Primed, Dose 1 [N=633,630] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Primed, Dose 1 [N=633,630] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Unprimed, Dose 2 [N=490,493] | 147 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Unprimed, Dose 2 [N=490,493] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Unprimed, Dose 2 [N=490,493] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Unprimed, Dose 2 [N=490,493] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Unprimed, Dose 2 [N=490,493] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling, Unprimed, Dose 2 [N=490,493] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Unprimed, Across Doses [N=523,521] | 223 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Unprimed, Across Doses [N=523,521] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Unprimed, Across Doses [N=523,521] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Unprimed, Across Doses[N=523,521] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Swelling, Unprimed, Across Doses [N=523,521] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Swelling,Unprimed, Across Doses[N=523,521] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Pain, Primed, Across Doses [N=633,630] | 239 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Pain, Primed, Across Doses [N=633,630] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Redness, Primed, Across Doses [N=633,630] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Redness, Primed, Across Doses [N=633,630] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Sweling, Primed, Across Doses [N=633,630] | 5 Subjects |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (Days 0 -180)
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), 6-17M [N=500,502] | 11 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), 18-35M [N=707,715] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s) [N=1207,1217] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), Unprimed [N=550,560] | 8 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), 6-17M [N=500,502] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), Unprimed [N=550,560] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s) [N=1207,1217] | 22 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), 18-35M [N=707,715] | 11 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), Primed [N=657,657] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), Primed [N=657,657] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), Primed [N=657,657] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s) [N=1207,1217] | 21 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s) [N=1207,1217] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), 6-17M [N=500,502] | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), 6-17M [N=500,502] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), 18-35M [N=707,715] | 10 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), 18-35M [N=707,715] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), Unprimed [N=550,560] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related SAE(s), Unprimed [N=550,560] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any SAE(s), Primed [N=657,657] | 8 Subjects |
Secondary
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature \< 38.0°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C.
Time frame: During a 2-day (Days 0-1) follow-up period after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Grade 3 Fever (>39.0°C), Across Doses[N=1159,1152] | 9 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Any Fever, Across Doses [N=1159,1152] | 82 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Fever (≥38.0°C), Dose 2 [N=490,495] | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Fever (≥38.0°C), Across Doses [N=1159,1152] | 42 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Any Fever, Dose 1 [N=1155,1148] | 63 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Any Fever, Dose 2 [N=490,495] | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Fever (≥38.0°C), Dose 1 [N=1155,1148] | 30 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Grade 3 Fever (>39.0°C), Dose 2 [N=490,495] | 3 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Grade 3 Fever (>39.0°C), Dose 1 [N=1155,1148] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Grade 3 Fever (>39.0°C), Dose 2 [N=490,495] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Grade 3 Fever (>39.0°C), Across Doses[N=1159,1152] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Grade 3 Fever (>39.0°C), Dose 1 [N=1155,1148] | 4 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Any Fever, Dose 2 [N=490,495] | 22 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Fever (≥38.0°C), Dose 2 [N=490,495] | 10 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Fever (≥38.0°C), Across Doses [N=1159,1152] | 43 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Any Fever, Across Doses [N=1159,1152] | 93 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Any Fever, Dose 1 [N=1155,1148] | 74 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | Fever (≥38.0°C), Dose 1 [N=1155,1148] | 34 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C.
Time frame: During the 7-day (Days 0-6) follow-up period after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 6-17M, Across Doses [N=481,470] | 238 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Dose 2 [N=490,495] | 110 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 6-17M, Across Doses[N=481,470] | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 6-17M, Dose 1 [N=478,467] | 273 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 6-17M, Across Doses[N=481,470] | 209 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, Dose 1 [N=1155,1148] | 280 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 6-17M, Across Doses [N=481,470] | 109 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 6-17M, Dose 1 [N=478,467] | 24 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 6-17M, Across Doses [N=481,470] | 60 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, Dose 2 [N=490,495] | 8 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 6-17M, Across Doses [N=481,470] | 17 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 6-17M, Dose 1 [N=478,467] | 239 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 6-17M, Across Doses [N=481,470] | 41 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Dose 1 [N=1155,1148] | 41 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°CRelated Fever,6-17M,Across Doses[N=481,470] | 39 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 6-17M, Dose 1 [N=478,467] | 141 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 6-17M, Across Doses [N=481,470] | 315 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, Dose 2 [N=490,495] | 91 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability,6-17M,Across Doses[N=481,470] | 36 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, 6-17M,Dose 1 [N=478,467] | 7 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability,6-17M,Across Doses[N=481,470] | 280 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Dose 2 [N=490,495] | 157 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite,6-17M,Across Doses[N=481,470] | 188 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, 6-17M, Dose 1[N=478,467] | 122 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 LossofAppetite,6-17M,AcrossDoses[N=481,470] | 14 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Across Doses [N=1159,1152] | 471 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related LossofAppetite,6-17M,AcrossDoses[N=481,470 | 159 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 18-35M, Dose 1 [N=677,681] | 224 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 18-35M, Across Doses [N=678,682] | 233 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Dose 1 [N=1155,1148] | 65 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness,18-35M, Across Doses[N=678,682] | 15 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 18-35M, Dose 1 [N=677,681] | 15 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness,18-35M,Across Doses [N=678,682] | 202 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Across Doses [N=1159,1152] | 36 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 18-35M, Across Doses [N=678,682] | 74 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 18-35M, Dose 1 [N=677,681] | 194 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 18-35M, Across Doses [N=678,682] | 31 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Dose 2 [N=490,495] | 10 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 18-35M, Across Doses [N=678,682] | 8 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 18-35M, Dose 1 [N=677,681] | 66 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 18-35M, Across Doses [N=678,682] | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Across Doses [N=1159,1152] | 411 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°CRelated Fever,18-35M,Across Doses[N=678,682 | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 18-35M, Dose 1 [N=677,681] | 25 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 18-35M, Across Doses [N=678,682] | 315 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Dose 1 [N=1155,1148] | 570 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Irritability,18-35M,Across Doses[N=678,682] | 25 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 18-35M, Dose 1 [N=677,681] | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability,18-35M,Across Doses[N=678,682 | 278 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Across Doses [N=1159,1152] | 183 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss ofAppetite,18-35M,Across Doses[N=678,682] | 203 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 18-35M, Dose 1 [N=677,681] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3LossofAppetite,18-35M,AcrossDoses[N=678,682] | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Dose 2 [N=490,495] | 133 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedLossofAppetite,18-35M,AcrossDoses[N=678,682 | 169 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 18-35M, Dose 1 [N=677,681] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Unprimed, Dose 1 [N=520,518] | 212 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Across Doses [N=1159,1152 | 91 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Unprimed, Dose 1 [N=520,518] | 15 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 18-35M, Dose 1 [N=677,681] | 297 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Unprimed, Dose 1 [N=520,518] | 182 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Dose 1 [N=1155,1148] | 31 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Unprimed, Dose 1 [N=520,518] | 80 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 18-35M, Dose 1 [N=677,681] | 20 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Unprimed, Dose 1 [N=520,518] | 41 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Across Doses [N=1159,1152] | 25 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Unprimed, Dose 1 [N=520,518] | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 18-35M, Dose 1 [N=677,681] | 260 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Unprimed, Dose 1 [N=520,518] | 24 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Dose 2 [N=490,495] | 60 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Unprimed, Dose 1[N=520,518] | 24 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 18-35M, Dose 1 [N=677,681] | 193 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Unprimed, Dose 1 [N=520,518] | 274 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Across Doses [N=1159,1152] | 62 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Unprimed, Dose 1 [N=520,518] | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite,18-35M,Dose 1 [N=677,681] | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Unprimed, Dose 1 [N=520,518] | 240 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Dose 1 [N=1155,1148] | 44 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Unprimed, Dose 1 [N=520,518] | 154 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,18-35M,Dose 1 [N=677,681] | 158 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Loss of Appetite,Unprimed,Dose 1[N=520,518] | 7 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Across Doses [N=1159,1152] | 60 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Unprimed,Dose1[N=520,518] | 129 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 6-17M, Dose 2 [N=373,374] | 129 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Primed, Dose 1 [N=635,630] | 212 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Dose 2 [N=490,495] | 31 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Primed, Dose 1 [N=635,630] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 6-17M, Dose 2 [N=373,374] | 10 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Primed, Dose 1 [N=635,630] | 183 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Across Doses [N=1159,1152] | 630 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Primed, Dose 1 [N=635,630] | 66 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 6-17M, Dose 2 [N=373,374] | 111 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C) Primed, Dose 1 [N=635,630] | 24 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Dose 1 [N=1155,1148] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Primed, Dose 1 [N=635,630] | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 6-17M, Dose 2 [N=373,374] | 47 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fevers, Primed, Dose 1 [N=635,630] | 17 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Across Doses [N=1159,1152] | 61 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Primed, Dose 1 [N=635,630] | 17 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 6-17M, Dose 2 [N=373,374] | 23 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Primed, Dose 1 [N=635,630] | 296 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Dose 2 [N=490,495] | 9 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Primed, Dose 1 [N=635,630] | 23 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 6-17M, Dose 2 [N=373,374] | 5 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Primed, Dose 1 [N=635,630] | 259 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Across Doses [N=1159,1152] | 558 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Primed, Dose 1 [N=635,630] | 180 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 6-17M, Dose 2 [N=373,374] | 17 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, Primed,Dose 1[N=635,630] | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Dose 1 [N=1155,1148] | 499 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Primed,Dose 1 [N=635,630] | 151 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 6-17M, Dose 2 [N=373,374] | 15 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Unprimed, Dose 2 [N=490,495] | 157 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Across Doses [N=1159,1152] | 391 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Unprimed, Dose 2 [N=490,495] | 10 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 6-17M, Dose 2 [N=373,374] | 168 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Unprimed, Dose 2 [N=490,495] | 133 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Dose 2 [N=490,495] | 22 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Unprimed, Dose 2 [N=490,495] | 60 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 6-17M, Dose 2 [N=373,374] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Unprimed, Dose 2 [N=490,495] | 31 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite,Across Doses[N=1159,1152 | 26 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Unprimed, Dose 2 [N=490,495] | 9 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 6-17M, Dose 2 [N=373,374] | 150 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Unprimed, Dose 2 [N=490,495] | 22 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Dose 1 [N=1155,1148] | 146 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Unprimed,Dose 2 [N=490,495] | 20 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 6-17M, Dose 2 [N=373,374] | 90 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Unprimed, Dose 2 [N=490,495] | 211 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Across Doses[N=1159,1152] | 328 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Unprimed, Dose 2 [N=490,495] | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, 6-17M, Dose 2[N=373,374] | 8 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Unprimed,Dose 2 [N=490,495] | 185 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Dose 2 [N=490,495] | 20 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Unprimed, Dose 2 [N=490,495] | 110 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, 6-17M Dose 2[N=373,374] | 73 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Loss of Appetite,Unprimed,Dose 2[N=490,495] | 8 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 6-17M, Dose 1 [N=478,467] | 200 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Unprimed,Dose 2[N=490,495 | 91 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 18-35M, Dose 2 [N=117,121] | 28 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Unprimed, Across Doses [N=524,522] | 259 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Dose 1 [N=1155,1148] | 334 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Drowsiness,Unprimed,Across Doses[N=524,522] | 20 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedDrowsiness,Unprimed,Across Doses[N=524,522] | 228 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 6-17M, Dose 1 [N=478,467] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Unprimed, Across Doses [N=524,522] | 117 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 18-35M, Dose 2 [N=117,121] | 22 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Unprimed,Across Doses [N=524,522] | 67 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Dose 2 [N=490,495] | 211 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Unprimed, Across Doses [N=524,522] | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 18-35M, Dose 2 [N=117,121] | 13 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Unprimed, Across Doses [N=524,522] | 45 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 6-17M, Dose 1 [N=478,467] | 171 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°CRelatedFever,Unprimed,AcrossDoses[N=524,522 | 43 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 18-35M, Dose 2 [N=117,121] | 8 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability,Unprimed, Across Doses[N=524,522] | 334 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Dose 1 [N=1155,1148] | 41 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3Irritability,Unprimed,AcrossDoses[N=524,522] | 38 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 18-35M, Dose 2 [N=117,121] | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedIrritability,Unprimed,AcrossDoses[N=524,522 | 299 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 6-17M, Dose 1 [N=478,467] | 80 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | AnyLoss ofAppetite,Unprimed,AcrossDoses[N=524,522] | 211 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 18-35M, Dose 2 [N=117,121] | 5 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3LossofAppetite,Unprimed,AcrossDosesN=524,522 | 14 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Dose 2 [N=490,495] | 21 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedLossofAppetite,UnprimedAcrossDosesN=524,522 | 177 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 18-35M, Dose 2 [N=117,121] | 5 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Primed, Across Doses [N=635,630] | 212 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 6-17M, Dose 1 [N=478,467] | 40 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Primed,Across Doses[N=635,630] | 16 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 18-35M, Dose 2 [N=117,121] | 43 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness,Primed,Across Doses[N=635,630] | 183 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, Dose 1 [N=1155,1148] | 19 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Primed, Across Doses [N=635,630] | 66 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 18-35M, Dose 2 [N=117,121] | 5 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Primed, Across Doses [N=635,630] | 24 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 6-17M, Dose 1 [N=478,467] | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Primed, Across Doses [N=635,630] | 4 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 18-35M, Dose 2 [N=117,121] | 35 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Primed, Across Doses [N=635,630] | 17 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Dose 2 [N=490,495] | 185 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C RelatedFever,Primed,Across Doses[N=635,630 | 17 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 18-35M, Dose 2 [N=117,121] | 20 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Primed, Across Doses [N=635,630] | 296 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 6-17M, Dose 1 [N=478,467] | 25 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Irritability,Primed,Across Doses[N=635,630] | 23 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, 18-35M,Dose 2[N=117,121] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability,Primed,AcrossDoses[N=635,630] | 259 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Dose 1 [N=1155,1148] | 365 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite,Primed,AcrossDoses[N=635,630] | 180 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, 18-35M,Dose 2[N=117,121] | 18 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 LossofAppetite,Primed,AcrossDoses[N=635,630 | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 6-17M, Dose 1 [N=478,467] | 25 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedLossofAppetite,Primed,AcrossDoses[N=635,630 | 151 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Dose 1 [N=1155,1148] | 424 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedLossofAppetite,Primed,AcrossDoses[N=635,630 | 171 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Dose 1 [N=1155,1148] | 424 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Dose 1 [N=1155,1148] | 30 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Dose 1 [N=1155,1148] | 381 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Dose 1 [N=1155,1148] | 147 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Dose 1 [N=1155,1148] | 67 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Dose 1 [N=1155,1148] | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Dose 1 [N=1155,1148] | 50 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Dose 1 [N=1155,1148] | 50 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Dose 1 [N=1155,1148] | 527 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Dose 1 [N=1155,1148] | 34 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Dose 1 [N=1155,1148] | 473 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Dose 1 [N=1155,1148] | 328 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, Dose 1 [N=1155,1148] | 15 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, Dose 1 [N=1155,1148] | 290 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Dose 2 [N=490,495] | 166 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Dose 2 [N=490,495] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Dose 2 [N=490,495] | 136 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Dose 2 [N=490,495] | 48 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Dose 2 [N=490,495] | 22 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Dose 2 [N=490,495] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Dose 2 [N=490,495] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Dose 2 [N=490,495] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Dose 2 [N=490,495] | 214 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Dose 2 [N=490,495] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Dose 2 [N=490,495] | 175 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Dose 2 [N=490,495] | 116 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, Dose 2 [N=490,495] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, Dose 2 [N=490,495] | 87 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Across Doses [N=1159,1152] | 471 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Across Doses [N=1159,1152] | 34 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Across Doses [N=1159,1152] | 425 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Across Doses [N=1159,1152] | 178 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Across Doses [N=1159,1152 | 86 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Across Doses [N=1159,1152] | 17 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Across Doses [N=1159,1152] | 63 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Across Doses [N=1159,1152] | 62 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Across Doses [N=1159,1152] | 582 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Across Doses [N=1159,1152] | 45 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Across Doses [N=1159,1152] | 525 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Across Doses [N=1159,1152] | 385 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite,Across Doses[N=1159,1152 | 19 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Across Doses[N=1159,1152] | 337 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 6-17M, Dose 1 [N=478,467] | 210 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 6-17M, Dose 1 [N=478,467] | 17 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 6-17M, Dose 1 [N=478,467] | 189 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 6-17M, Dose 1 [N=478,467] | 70 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 6-17M, Dose 1 [N=478,467] | 31 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 6-17M, Dose 1 [N=478,467] | 4 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 6-17M, Dose 1 [N=478,467] | 26 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 6-17M, Dose 1 [N=478,467] | 26 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 6-17M, Dose 1 [N=478,467] | 252 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 6-17M, Dose 1 [N=478,467] | 15 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 6-17M, Dose 1 [N=478,467] | 227 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 6-17M, Dose 1 [N=478,467] | 131 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, 6-17M,Dose 1 [N=478,467] | 4 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, 6-17M, Dose 1[N=478,467] | 115 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 18-35M, Dose 1 [N=677,681] | 214 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 18-35M, Dose 1 [N=677,681] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 18-35M, Dose 1 [N=677,681] | 192 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 18-35M, Dose 1 [N=677,681] | 77 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 18-35M, Dose 1 [N=677,681] | 36 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 18-35M, Dose 1 [N=677,681] | 7 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 18-35M, Dose 1 [N=677,681] | 24 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 18-35M, Dose 1 [N=677,681] | 24 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 18-35M, Dose 1 [N=677,681] | 275 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 18-35M, Dose 1 [N=677,681] | 19 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 18-35M, Dose 1 [N=677,681] | 246 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 18-35M, Dose 1 [N=677,681] | 197 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite,18-35M,Dose 1 [N=677,681] | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,18-35M,Dose 1 [N=677,681] | 175 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 6-17M, Dose 2 [N=373,374] | 142 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 6-17M, Dose 2 [N=373,374] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 6-17M, Dose 2 [N=373,374] | 115 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 6-17M, Dose 2 [N=373,374] | 38 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 6-17M, Dose 2 [N=373,374] | 16 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 6-17M, Dose 2 [N=373,374] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 6-17M, Dose 2 [N=373,374] | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 6-17M, Dose 2 [N=373,374] | 10 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 6-17M, Dose 2 [N=373,374] | 177 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 6-17M, Dose 2 [N=373,374] | 12 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 6-17M, Dose 2 [N=373,374] | 141 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 6-17M, Dose 2 [N=373,374] | 91 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, 6-17M, Dose 2[N=373,374] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, 6-17M Dose 2[N=373,374] | 66 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 18-35M, Dose 2 [N=117,121] | 24 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 18-35M, Dose 2 [N=117,121] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 18-35M, Dose 2 [N=117,121] | 21 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 18-35M, Dose 2 [N=117,121] | 10 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 18-35M, Dose 2 [N=117,121] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 18-35M, Dose 2 [N=117,121] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 18-35M, Dose 2 [N=117,121] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, 18-35M, Dose 2 [N=117,121] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 18-35M, Dose 2 [N=117,121] | 37 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, 18-35M, Dose 2 [N=117,121] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, 18-35M, Dose 2 [N=117,121] | 34 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, 18-35M, Dose 2 [N=117,121] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, 18-35M,Dose 2[N=117,121] | 2 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite, 18-35M,Dose 2[N=117,121] | 21 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 6-17M, Across Doses [N=481,470] | 248 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, 6-17M, Across Doses[N=481,470] | 21 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, 6-17M, Across Doses[N=481,470] | 224 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 6-17M, Across Doses [N=481,470] | 93 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 6-17M, Across Doses [N=481,470] | 45 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 6-17M, Across Doses [N=481,470] | 7 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 6-17M, Across Doses [N=481,470] | 36 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°CRelated Fever,6-17M,Across Doses[N=481,470] | 35 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 6-17M, Across Doses [N=481,470] | 297 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability,6-17M,Across Doses[N=481,470] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability,6-17M,Across Doses[N=481,470] | 269 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite,6-17M,Across Doses[N=481,470] | 175 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 LossofAppetite,6-17M,AcrossDoses[N=481,470] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related LossofAppetite,6-17M,AcrossDoses[N=481,470 | 148 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, 18-35M, Across Doses [N=678,682] | 223 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness,18-35M, Across Doses[N=678,682] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness,18-35M,Across Doses [N=678,682] | 201 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, 18-35M, Across Doses [N=678,682] | 85 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), 18-35M, Across Doses [N=678,682] | 41 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, 18-35M, Across Doses [N=678,682] | 10 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, 18-35M, Across Doses [N=678,682] | 27 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°CRelated Fever,18-35M,Across Doses[N=678,682 | 27 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, 18-35M, Across Doses [N=678,682] | 285 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Irritability,18-35M,Across Doses[N=678,682] | 20 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability,18-35M,Across Doses[N=678,682 | 256 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss ofAppetite,18-35M,Across Doses[N=678,682] | 210 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3LossofAppetite,18-35M,AcrossDoses[N=678,682] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedLossofAppetite,18-35M,AcrossDoses[N=678,682 | 189 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Unprimed, Dose 1 [N=520,518] | 211 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Unprimed, Dose 1 [N=520,518] | 19 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Unprimed, Dose 1 [N=520,518] | 189 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Unprimed, Dose 1 [N=520,518] | 69 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Unprimed, Dose 1 [N=520,518] | 33 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Unprimed, Dose 1 [N=520,518] | 3 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Unprimed, Dose 1 [N=520,518] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Unprimed, Dose 1[N=520,518] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Unprimed, Dose 1 [N=520,518] | 256 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Unprimed, Dose 1 [N=520,518] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Unprimed, Dose 1 [N=520,518] | 227 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Unprimed, Dose 1 [N=520,518] | 138 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Loss of Appetite,Unprimed,Dose 1[N=520,518] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Unprimed,Dose1[N=520,518] | 119 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Primed, Dose 1 [N=635,630] | 213 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Primed, Dose 1 [N=635,630] | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Primed, Dose 1 [N=635,630] | 192 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Primed, Dose 1 [N=635,630] | 78 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C) Primed, Dose 1 [N=635,630] | 34 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Primed, Dose 1 [N=635,630] | 8 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fevers, Primed, Dose 1 [N=635,630] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Primed, Dose 1 [N=635,630] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Primed, Dose 1 [N=635,630] | 271 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Primed, Dose 1 [N=635,630] | 20 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Primed, Dose 1 [N=635,630] | 246 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Primed, Dose 1 [N=635,630] | 190 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Loss of Appetite, Primed,Dose 1[N=635,630] | 9 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Primed,Dose 1 [N=635,630] | 171 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Unprimed, Dose 2 [N=490,495] | 166 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Unprimed, Dose 2 [N=490,495] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness, Unprimed, Dose 2 [N=490,495] | 136 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Unprimed, Dose 2 [N=490,495] | 48 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Unprimed, Dose 2 [N=490,495] | 22 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Unprimed, Dose 2 [N=490,495] | 6 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Unprimed, Dose 2 [N=490,495] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C Related Fever, Unprimed,Dose 2 [N=490,495] | 13 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Unprimed, Dose 2 [N=490,495] | 214 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Irritability, Unprimed, Dose 2 [N=490,495] | 14 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability, Unprimed,Dose 2 [N=490,495] | 175 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite, Unprimed, Dose 2 [N=490,495] | 116 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Loss of Appetite,Unprimed,Dose 2[N=490,495] | 5 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Loss of Appetite,Unprimed,Dose 2[N=490,495 | 87 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Unprimed, Across Doses [N=524,522] | 258 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Drowsiness,Unprimed,Across Doses[N=524,522] | 23 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedDrowsiness,Unprimed,Across Doses[N=524,522] | 233 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Unprimed, Across Doses [N=524,522] | 100 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Unprimed,Across Doses [N=524,522] | 52 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Unprimed, Across Doses [N=524,522] | 9 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Unprimed, Across Doses [N=524,522] | 38 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°CRelatedFever,Unprimed,AcrossDoses[N=524,522 | 37 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability,Unprimed, Across Doses[N=524,522] | 311 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3Irritability,Unprimed,AcrossDoses[N=524,522] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedIrritability,Unprimed,AcrossDoses[N=524,522 | 279 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | AnyLoss ofAppetite,Unprimed,AcrossDoses[N=524,522] | 195 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3LossofAppetite,Unprimed,AcrossDosesN=524,522 | 10 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | RelatedLossofAppetite,UnprimedAcrossDosesN=524,522 | 166 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Drowsiness, Primed, Across Doses [N=635,630] | 213 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Drowsiness, Primed,Across Doses[N=635,630] | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Drowsiness,Primed,Across Doses[N=635,630] | 192 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Fever, Primed, Across Doses [N=635,630] | 78 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Fever (≥38.0°C), Primed, Across Doses [N=635,630] | 34 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Fever, Primed, Across Doses [N=635,630] | 8 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Fever, Primed, Across Doses [N=635,630] | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | ≥38.0°C RelatedFever,Primed,Across Doses[N=635,630 | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Irritability, Primed, Across Doses [N=635,630] | 271 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 Irritability,Primed,Across Doses[N=635,630] | 20 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Irritability,Primed,AcrossDoses[N=635,630] | 246 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Loss of Appetite,Primed,AcrossDoses[N=635,630] | 190 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade3 LossofAppetite,Primed,AcrossDoses[N=635,630 | 9 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.
Time frame: During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, 6-17M [N=500,502] | 32 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, 18-35M [N=707,715] | 35 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs [N=1207,1217] | 70 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, Unprimed [N=550,560] | 310 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, 6-17M [N=500,502] | 36 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, Unprimed [N=550,560] | 35 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, 6-17M [N=500,502] | 268 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, Unprimed [N=550,560] | 40 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, 18-35M [N=707,715] | 281 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, Primed [N=657,657] | 239 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs [N=1207,1217] | 71 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, Primed [N=657,657] | 35 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, 18-35M [N=707,715] | 38 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, Primed [N=657,657] | 31 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs [N=1207,1217] | 549 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, Primed [N=657,657] | 36 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs [N=1207,1217] | 537 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs [N=1207,1217] | 75 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs [N=1207,1217] | 71 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, 6-17M [N=500,502] | 270 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, 6-17M [N=500,502] | 48 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, 6-17M [N=500,502] | 33 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, 18-35M [N=707,715] | 267 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, 18-35M [N=707,715] | 27 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, 18-35M [N=707,715] | 38 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, Unprimed [N=550,560] | 302 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, Unprimed [N=550,560] | 48 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related Unsolicited AEs, Unprimed [N=550,560] | 35 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any Unsolicited AEs, Primed [N=657,657] | 235 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Grade 3 Unsolicited AEs, Primed [N=657,657] | 27 Subjects |
Secondary
Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
Time frame: During the entire study period (Days 0 -180)
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), 6-17M [N=500,502] | 322 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), Unprimed [N=550,560] | 344 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), 18-35M [N=707,715] | 405 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), Primed [N=657,657] | 383 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s) [N=1207,1217] | 727 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), Primed [N=657,657] | 382 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s) [N=1207,1217] | 719 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), 6-17M [N=500,502] | 323 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), 18-35M [N=707,715] | 396 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). | Any MAE(s), Unprimed [N=550,560] | 337 Subjects |
Secondary
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (Days 0 -180)
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), 6-17M [N=500,502] | 1 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), 18-35M [N=707,715] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), Unprimed [N=550,560] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s) [N=1207,1217] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), Unprimed [N=550,560] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), 6-17M [N=500,502] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), Primed [N=657,657] | 1 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s) [N=1207,1217] | 1 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), Primed [N=657,657] | 0 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), 18-35M [N=707,715] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), Primed [N=657,657] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s) [N=1207,1217] | 1 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s) [N=1207,1217] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), 6-17M [N=500,502] | 1 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), 6-17M [N=500,502] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), 18-35M [N=707,715] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), Unprimed [N=550,560] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), Unprimed [N=550,560] | 0 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Any pIMD(s), Primed [N=657,657] | 1 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Related pIMD(s), 18-35M [N=707,715] | 0 Subjects |
Secondary
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
Population: The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 0 | 2 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 0 | 159 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 28/Day 56 | 313 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 28/56 | 983 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 0 | 38 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 28/Day 56 | 569 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 28/Day 56 | 356 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 28/56 | 814 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 0 | 42 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 0 | 12 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 56 | 282 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 0 | 40 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 0 | 149 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 28/Day 56 | 281 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 28 | 532 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 28/56 | 833 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 0 | 27 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 0 | 123 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 56 | 321 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 28/56 | 669 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 0 | 108 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 28/Day 56 | 552 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 28 | 512 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 0 | 191 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 0 | 65 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 0 | 64 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 56 | 407 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 0 | 32 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 0 | 259 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 0 | 324 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 28 | 576 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 0 | 260 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 0 | 9 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 28/Day 56 | 245 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 56 | 379 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 28/Day 56 | 606 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 0 | 31 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 0 | 135 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 28 | 290 Subjects |
| FluLaval™ Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 28/Day 56 | 377 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 28 | 235 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 0 | 190 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Day 28/56 | 775 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 0 | 140 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Day 28/56 | 800 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 0 | 336 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Day 28/56 | 911 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 0 | 46 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Day 28/56 | 512 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 0 | 25 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 6-17M, Day 28/Day 56 | 240 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 0 | 165 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, 18-35M, Day 28/Day 56 | 535 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 0 | 15 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 6-17M, Day 28/Day 56 | 272 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 0 | 125 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, 18-35M, Day 28/Day 56 | 528 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 0 | 70 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 6-17M, Day 28/Day 56 | 311 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 0 | 266 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, 18-35M, Day 28/Day 56 | 600 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 0 | 7 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 6-17M, Day 28/Day 56 | 206 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 0 | 39 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, 18-35M, Day 28/Day 56 | 306 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 0 | 46 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Unprimed, Day 56 | 294 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 0 | 144 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H1N1, Primed, Day 28 | 481 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 0 | 31 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Unprimed, Day 56 | 330 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 0 | 109 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | H3N2, Primed, Day 28 | 470 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 0 | 80 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Unprimed, Day 56 | 362 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 0 | 256 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Yamagata, Primed, Day 28 | 549 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 0 | 11 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Unprimed, Day 56 | 277 Subjects |
| Fluzone® Quadrivalent Group | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | Victoria, Primed, Day 0 | 35 Subjects |