Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345

Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01702454

Enrollment

470

Registered

2012-10-08

Start date

2012-10-06

Completion date

2013-06-05

Last updated

2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

GSK Biologicals quadrivalent influenza vaccine, Influenza, Children, Safety, Immunogenicity

Brief summary

The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).

Interventions

BIOLOGICALFluarix Quadrivalent

1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Months to 48 Months

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol. * Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360). * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Exclusion criteria

* Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study. * Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2. * Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Any contraindication to intramuscular injection. * Acute disease and/or fever at the time of enrollment: * Fever is defined as temperature ≥ 37.5°C 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 other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Design outcomes

Primary

Measure	Time frame	Description
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	At Day 0 and Day 7	Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	At Day 0 and Day 7	Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 7 post dose 1	A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 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 included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 7 post dose 1	MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 0 and Day 7	Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 0 and Day 7	Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	At Day 0 and Day 7	Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 7 post dose 1	Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 0 and Day 7	Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Secondary

Measure	Time frame	Description
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	At Day 7 post dose 1	VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	At Day 7 post dose 1	MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	At Day 0 and Day 7	Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	At Day 0 and Day 7	Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	At Day 7 post dose 1	VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	At Day 7 post dose 1	MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	At Day 7 post dose 1	VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 0 and Day 7	The cut-off values assessed were less than (\<) 1:10, 1:10 to \< 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	During a 7-day (Day 0 to 6) follow-up period after first vaccination	Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Duration of Solicted Symptoms	During the 7-day (Days 0-6) post-vaccination Dose 1 period	Duration was defined as number of days with any grade of solicted local and/or general symptoms
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	During the 7 days (Days 0 - 6) post dose 1 vaccination	Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature \> 39.0°C.
Number of Subjects Reporting AEs With Medically Attended Visits (MAV)	During the entire study period (Day 0 - Day 179)	MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)	During the entire study period (Days 0 - 179)	pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.	Within 28 days (Days 0-27) after first vaccination	Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)	During the entire study period (Day 0 - Day 179)	A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	At Day 7 post dose 1	MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	At Day 0 and Day 7	Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	At Day 0 and Day 7	Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	At Day 7 post dose 1	VRR was defined as the number of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 7 post dose 1	MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	At Day 7 post dose 1	VRR was defined as the number of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 7 post dose 1	MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	At Day 0 and Day 7	MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	At Day 7 post dose 1	VRR was defined as the number of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Countries

Czechia, Poland, Spain, United Kingdom

Participant flow

Participants by arm

Arm	Count
Fluarix Quadrivalent Primed Group Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.	241
Fluarix Quadrivalent Unprimed Group Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.	229
Total	470

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Consent withdrawal	0	1
Overall Study	Lost to Follow-up	3	6
Overall Study	Migrated/moved from study area	0	1

Baseline characteristics

Characteristic	Fluarix Quadrivalent Primed Group	Fluarix Quadrivalent Unprimed Group	Total
Age, Continuous	33.2 Years STANDARD_DEVIATION 7.54	32.5 Years STANDARD_DEVIATION 7.39	32.8 Years STANDARD_DEVIATION 7.47
Sex: Female, Male Female	114 Participants	96 Participants	210 Participants
Sex: Female, Male Male	127 Participants	133 Participants	260 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	145 / 241	138 / 229
serious Total, serious adverse events	7 / 241	8 / 229

Outcome results

Primary

Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 7 post dose 1

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1	10.3 Fold increase
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2	10.9 Fold increase
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria	6.7 Fold increase
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata	15.2 Fold increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata	4.0 Fold increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1	3.2 Fold increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria	4.6 Fold increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2	2.9 Fold increase

Primary

Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 7 post dose 1

Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=210,173]	10.0 Fold Increase
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=210,173]	11.2 Fold Increase
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=210,173]	6.9 Fold Increase
Fluarix Quadrivalent Primed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=210,173]	15.2 Fold Increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=210,173]	4.0 Fold Increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=210,173]	3.1 Fold Increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=210,173]	4.5 Fold Increase
Fluarix Quadrivalent Unprimed Group	Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=210,173]	2.4 Fold Increase

Primary

Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=224,209]	218 Subjects
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=221,202]	189 Subjects
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=221,202]	187 Subjects
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=224,209]	220 Subjects
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=224,209]	224 Subjects
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=224,209]	222 Subjects
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=221,202]	134 Subjects
Fluarix Quadrivalent Primed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=221,202]	131 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=221,202]	36 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=221,202]	79 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=224,209]	144 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=224,209]	137 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=224,209]	99 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=221,202]	58 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=224,209]	174 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=221,202]	64 Subjects

Primary

Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 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 included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1	170 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2	180 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria	169 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata	208 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata	77 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1	65 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria	78 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2	73 Subjects

Comparison: To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.95% CI: [35.87, 52.84]

Primary

Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

A seroconverted subject was defined as a subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=210,173]	160 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=210,173]	173 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=210,173]	162 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=210,173]	197 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=210,173]	65 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=210,173]	54 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=210,173]	66 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=210,173]	49 Subjects

Primary

Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=210,173]	178 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=213,179]	209 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=210,173]	120 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=213,179]	207 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Victoria, Day 0[ N=210,173]	177 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Victoria, Day 7[ N=213,179]	213 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Yamagata, Day 0[ N=210,173]	127 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=213,179]	211 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=213,179]	120 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=210,173]	54 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Victoria, Day 0[ N=210,173]	50 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=213,179]	113 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Yamagata, Day 0[ N=210,173]	31 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=210,173]	52 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	Victoria, Day 7[ N=213,179]	145 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=213,179]	72 Subjects

Primary

Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0 [N=221,202]	89 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0 [N=221,202]	72 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=224,209]	217 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0 [N=221,202]	37 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0 [N=221,202]	27 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=224,209]	217 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=224,209]	216 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=224,209]	193 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=224,209]	83 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0 [N=221,202]	61 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=224,209]	72 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0 [N=221,202]	74 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=224,209]	81 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=224,209]	84 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0 [N=221,202]	12 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0 [N=221,202]	39 Subjects

Comparison: To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains95% CI: [55.27, 68.89]

Primary

Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0 [N=210,173]	29 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1,Day 0 [N=210,173]	87 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=213,179]	182 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0 [N=210,173]	27 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=213,179]	206 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=213,179]	206 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=213,179]	205 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0 [N=210,173]	68 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=213,179]	70 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0 [N=210,173]	10 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1,Day 0 [N=210,173]	51 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=213,179]	59 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0 [N=210,173]	48 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0 [N=210,173]	35 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=213,179]	70 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=213,179]	54 Subjects

Primary

Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=221,202]	28.5 Titer
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=221,202]	12.3 Titer
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=224,209]	193.9 Titer
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=221,202]	43.1 Titer
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=221,202]	11.9 Titer
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=224,209]	135.3 Titer
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=224,209]	182.6 Titer
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=224,209]	445.6 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=224,209]	26.1 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=221,202]	14.5 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=221,202]	16.4 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=224,209]	47.5 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=221,202]	10.0 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=224,209]	47.1 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=221,202]	6.5 Titer
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=224,209]	45.8 Titer

Comparison: The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.95% CI: [6.21, 12.96]

Comparison: The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.95% CI: [1.81, 4.02]

Comparison: The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.95% CI: [2.89, 5.37]

Comparison: The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.95% CI: [5.21, 8.63]

Primary

Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0 [N=210,173]	44.0 Titers
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=213,179]	442.3 Titers
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=213,179]	125.9 Titers
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0 [N=210,173]	11.0 Titers
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0 [N=210,173]	27.8 Titers
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=213,179]	193.3 Titers
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0 [N=210,173]	11.9 Titers
Fluarix Quadrivalent Primed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=213,179]	184.1 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7 [N=213,179]	25.2 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0 [N=210,173]	14.3 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0 [N=210,173]	10.3 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7 [N=213,179]	42.7 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0 [N=210,173]	11.9 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0 [N=210,173]	6.5 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7 [N=213,179]	46.1 Titers
Fluarix Quadrivalent Unprimed Group	Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7 [N=213,179]	28.7 Titers

Secondary

Duration of Solicted Symptoms

Duration was defined as number of days with any grade of solicted local and/or general symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination Dose 1 period

Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

Arm	Measure	Group	Value (MEDIAN)
Fluarix Quadrivalent Primed Group	Duration of Solicted Symptoms	Redness	2.0 Days
Fluarix Quadrivalent Primed Group	Duration of Solicted Symptoms	Temperature	1.0 Days
Fluarix Quadrivalent Primed Group	Duration of Solicted Symptoms	Drowsiness	1.0 Days
Fluarix Quadrivalent Primed Group	Duration of Solicted Symptoms	Pain	1.0 Days
Fluarix Quadrivalent Primed Group	Duration of Solicted Symptoms	Irritability/fussiness	2.0 Days
Fluarix Quadrivalent Primed Group	Duration of Solicted Symptoms	Swelling	2.0 Days
Fluarix Quadrivalent Primed Group	Duration of Solicted Symptoms	Loss of appetite	2.0 Days
Fluarix Quadrivalent Unprimed Group	Duration of Solicted Symptoms	Temperature	2.0 Days
Fluarix Quadrivalent Unprimed Group	Duration of Solicted Symptoms	Loss of appetite	2.0 Days
Fluarix Quadrivalent Unprimed Group	Duration of Solicted Symptoms	Pain	1.0 Days
Fluarix Quadrivalent Unprimed Group	Duration of Solicted Symptoms	Redness	2.0 Days
Fluarix Quadrivalent Unprimed Group	Duration of Solicted Symptoms	Swelling	1.0 Days
Fluarix Quadrivalent Unprimed Group	Duration of Solicted Symptoms	Drowsiness	1.0 Days
Fluarix Quadrivalent Unprimed Group	Duration of Solicted Symptoms	Irritability/fussiness	2.0 Days

Secondary

MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7[N=98,86]	8.1 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7[N=100,86]	5.0 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7[N=98,86]	5.2 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7[N=99,86]	8.7 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7[N=99,86]	2.6 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7[N=98,86]	1.7 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7[N=98,86]	1.9 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7[N=100,86]	1.8 Fold increase

Secondary

MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 [N=105,106]	8.3 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 [N=105,106]	5.2 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria [N=105,106]	8.8 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata [N=107,106]	4.9 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata [N=107,106]	2.0 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 [N=105,106]	1.8 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria [N=105,106]	2.7 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 [N=105,106]	1.9 Fold increase

Secondary

MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.

MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.

Time frame: At Day 7 post dose 1

Population: Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2, Day 7,17-29M[N=53,52]	4.6 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,17-29M[53,52]	11.4 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,30-48M[N=52,54]	6.0 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2, Day 7,30-48M[N=54,54]	5.3 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria, Day 7,17-29M[N=53,52]	5.2 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria, Day 7,30-48M[N=52,54]	5.1 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7, 17-29M[N=53,52]	8.8 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7, 30-48M[N=52,54]	8.7 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2, Day 7,17-29M[N=53,52]	1.7 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2, Day 7,30-48M[N=54,54]	2.3 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria, Day 7,17-29M[N=53,52]	1.5 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7, 30-48M[N=52,54]	3.2 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7, 17-29M[N=53,52]	2.2 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,17-29M[53,52]	1.5 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria, Day 7,30-48M[N=52,54]	2.3 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,30-48M[N=52,54]	2.1 Fold Increase

Secondary

MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria [N=107,108]	5.0 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 [N=97, 89]	10.6 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata [N=107,105]	5.0 Fold increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 [N=97, 94]	6.4 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata [N=107,105]	1.7 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 [N=97, 94]	4.5 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria [N=107,108]	2.1 Fold increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 [N=97, 89]	3.1 Fold increase

Secondary

MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7[N=100,88]	5.1 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7[N=90,71]	10.0 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7[N=100,86]	4.8 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7[N=90,74]	6.2 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7[N=100,86]	1.6 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7[N=90,71]	3.1 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7[N=100,88]	2.2 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7[N=90,74]	3.4 Fold Increase

Secondary

MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata

MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7, 30-48M[N=50,45]	8.7 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,17-29M[N=53,53]	5.4 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,30-48M[N=49,48]	6.7 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,30-48M[N=54,55]	4.7 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,17-29M[N=48,46]	6.1 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,17-29M[N=53,51]	4.4 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,30-48M[N=54,54]	5.5 Fold Increase
Fluarix Quadrivalent Primed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7, 17-29M[N=47,44]	13.1 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,30-48M[N=54,54]	1.8 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7, 17-29M[N=47,44]	2.0 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,17-29M[N=48,46]	3.4 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,17-29M[N=53,51]	1.5 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7, 30-48M[N=50,45]	4.7 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,30-48M[N=49,48]	5.9 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,17-29M[N=53,53]	1.8 Fold Increase
Fluarix Quadrivalent Unprimed Group	MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,30-48M[N=54,55]	2.5 Fold Increase

Secondary

Number of Subjects Reporting AEs With Medically Attended Visits (MAV)

MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.

Time frame: During the entire study period (Day 0 - Day 179)

Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting AEs With Medically Attended Visits (MAV)	Related MAV	0 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting AEs With Medically Attended Visits (MAV)	Any MAV	149 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting AEs With Medically Attended Visits (MAV)	Grade 3 MAV	5 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting AEs With Medically Attended Visits (MAV)	Grade 3 MAV	8 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting AEs With Medically Attended Visits (MAV)	Related MAV	1 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting AEs With Medically Attended Visits (MAV)	Any MAV	130 Subjects

Secondary

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).

Time frame: During a 7-day (Day 0 to 6) follow-up period after first vaccination

Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any Redness	82 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 Swelling	2 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 Redness	2 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 Pain	2 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any Swelling	49 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any Pain	96 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 Swelling	0 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any Pain	61 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 Pain	1 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any Redness	48 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 Redness	0 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any Swelling	25 Subjects

Secondary

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Time frame: During the entire study period (Day 0 - Day 179)

Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)	Any SAE(s)	7 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)	Related SAE(s)	0 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)	Any SAE(s)	8 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)	Related SAE(s)	0 Subjects

Secondary

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.

Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature \> 39.0°C.

Time frame: During the 7 days (Days 0 - 6) post dose 1 vaccination

Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Drowsiness	36 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Irritability/Fussiness	5 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Temperature	13 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Loss of appetite	51 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Drowsiness	54 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Loss of appetite	8 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Irritability/Fussiness	51 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Loss of appetite	31 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Drowsiness	5 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Temperature	2 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Temperature	6 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Irritability/Fussiness	77 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Temperature	15 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Irritability/Fussiness	59 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Loss of appetite	31 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Temperature	1 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Drowsiness	44 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Drowsiness	1 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Irritability/Fussiness	5 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Irritability/Fussiness	43 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Loss of appetite	46 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Grade 3 Loss of appetite	5 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Any Temperature	26 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	Related Drowsiness	28 Subjects

Secondary

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

Time frame: Within 28 days (Days 0-27) after first vaccination

Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.	Any Unsolicted AEs	66 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.	Grade 3 Unsolicted AEs	6 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.	Related Unsolicted AEs	5 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.	Any Unsolicted AEs	66 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.	Grade 3 Unsolicted AEs	7 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.	Related Unsolicted AEs	3 Subjects

Secondary

Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)

pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.

Time frame: During the entire study period (Days 0 - 179)

Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)	Any pIMD	0 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)	Related pIMD	0 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)	Any pIMD	0 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)	Related pIMD	0 Subjects

Secondary

Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

The cut-off values assessed were less than (\<) 1:10, 1:10 to \< 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (<1:10), Day 7 [N=224,209]	0 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (<1:10), Day 0 [N=221,202]	87 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (1:10 to <1:40), Day 0 [N=221,202]	115 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (1:10 to <1:40), Day 0 [N=221,202]	107 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (≥1: 40), Day 7 [N=224,209]	216 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (<1:10), Day 0 [N=221,202]	32 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (<1:10), Day 7 [N=224,209]	4 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (<1:10), Day 0 [N=221,202]	90 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (<1:10), Day 7 [N=224,209]	6 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (<1:10), Day 0 [N=221,202]	34 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (<1:10), Day 7 [N=224,209]	2 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (1:10 to <1:40), Day 0 [N=221,202]	100 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (1:10 to <1:40), Day 7 [N=224,209]	3 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (1:10 to <1:40), Day 0 [N=221,202]	94 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (1:10 to <1:40), Day 7 [N=224,209]	25 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (1:10 to <1:40), Day 7 [N=224,209]	7 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (1:10 to <1:40), Day 7 [N=224,209]	6 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (≥1: 40), Day 0 [N=221,202]	89 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (≥1: 40), Day 7 [N=224,209]	217 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (≥1: 40), Day 0 [N=221,202]	37 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (≥1: 40), Day 7 [N=224,209]	193 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (≥1: 40), Day 0 [N=221,202]	72 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (≥1: 40), Day 7 [N=224,209]	217 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (≥1: 40), Day 0 [N=221,202]	27 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (≥1: 40), Day 7 [N=224,209]	84 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (<1:10), Day 7 [N=224,209]	35 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (1:10 to <1:40), Day 7 [N=224,209]	65 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (<1:10), Day 0 [N=221,202]	166 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (1:10 to <1:40), Day 7 [N=224,209]	18 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (≥1: 40), Day 7 [N=224,209]	72 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (1:10 to <1:40), Day 7 [N=224,209]	90 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (1:10 to <1:40), Day 0 [N=221,202]	5 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (≥1: 40), Day 0 [N=221,202]	39 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (≥1: 40), Day 7 [N=224,209]	83 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (1:10 to <1:40), Day 0 [N=221,202]	19 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (<1:10), Day 0 [N=221,202]	138 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (≥1: 40), Day 0 [N=221,202]	74 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (<1:10), Day 7 [N=224,209]	72 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (1:10 to <1:40), Day 0 [N=221,202]	24 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (<1:10), Day 0 [N=221,202]	123 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (≥1: 40), Day 0 [N=221,202]	12 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (<1:10), Day 7 [N=224,209]	110 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (1:10 to <1:40), Day 7 [N=224,209]	61 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria (<1:10), Day 0 [N=221,202]	144 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2 (≥1: 40), Day 7 [N=224,209]	81 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata (<1:10), Day 7 [N=224,209]	65 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (≥1: 40), Day 0 [N=221,202]	61 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1 (1:10 to <1:40), Day 0 [N=221,202]	3 Subjects

Secondary

Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

The cut-off values assessed were less than (\<) 1:10, 1:10 to \< 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, ≥1:80 [N=210,173]	73 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, 1:10 to <1:40 [N=210,173]	178 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, ≥1:80 [N=213,179]	204 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, ≥1:80 [N=213,179]	182 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, <1:10 [N=210,173]	32 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, <1:10 [N=213,179]	4 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, 1:10 to <1:40 [N=213,179]	209 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, ≥1:40 [N=210,173]	87 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, ≥1:40 [N=213,179]	206 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, ≥1:60 [N=210,173]	73 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, ≥1:60 [N=213,179]	204 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, <1:10 [N=210,173]	90 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, <1:10 [N=213,179]	6 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0,1:10 to 1:40 [N=210,173]	120 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7,1:10 to 1:40 [N=213,179]	207 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, ≥1:40 [N=210,173]	29 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, ≥1:40 [N=213,179]	182 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, ≥1:60 [N=210,173]	12 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, ≥1:60 [N=213,179]	147 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, ≥1:80 [N=210,173]	12 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, ≥1:80 [N=213,179]	147 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, <1:10 [N=210,173]	33 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, <1:10 [N=213,179]	0 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0,1:10 to 1:40 [N=210,173]	177 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7,1:10 to 1:40 [N=213,179]	213 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, ≥1:40 [N=210,173]	68 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, ≥1:40 [N=213,179]	206 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, ≥1:60 [N=210,173]	40 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, ≥1:60 [N=213,179]	182 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, ≥1:80 [N=210,173]	40 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, <1:10 [N=210,173]	83 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, <1:10 [N=213,179]	2 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0,1:10 to 1:40 [N=210,173]	127 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7,1:10 to 1:40 [N=213,179]	211 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, ≥1:40 [N=210,173]	27 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, ≥1:40 [N=213,179]	205 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, ≥1:60 [N=210,173]	7 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, ≥1:60 [N=213,179]	177 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, ≥1:80 [N=210,173]	7 Subjects
Fluarix Quadrivalent Primed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, ≥1:80 [N=213,179]	177 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, ≥1:60 [N=213,179]	44 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, ≥1:80 [N=213,179]	52 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, 1:10 to <1:40 [N=210,173]	54 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, ≥1:80 [N=210,173]	47 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, <1:10 [N=210,173]	142 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, <1:10 [N=210,173]	123 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, ≥1:80 [N=213,179]	51 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, ≥1:40 [N=213,179]	70 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, <1:10 [N=210,173]	119 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, <1:10 [N=213,179]	34 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, <1:10 [N=213,179]	59 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, 1:10 to <1:40 [N=213,179]	113 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0,1:10 to 1:40 [N=210,173]	50 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, ≥1:40 [N=210,173]	51 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7, ≥1:80 [N=213,179]	44 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, ≥1:40 [N=213,179]	59 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7,1:10 to 1:40 [N=213,179]	145 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 0, ≥1:60 [N=210,173]	47 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0,1:10 to 1:40 [N=210,173]	31 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, ≥1:60 [N=213,179]	57 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, <1:10 [N=213,179]	66 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1, Day 7, ≥1:80 [N=213,179]	57 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, ≥1:40 [N=210,173]	35 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, <1:10 [N=210,173]	121 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, ≥1:60 [N=210,173]	4 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, <1:10 [N=213,179]	107 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, ≥1:40 [N=213,179]	70 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0,1:10 to 1:40 [N=210,173]	52 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7,1:10 to 1:40 [N=213,179]	120 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7,1:10 to 1:40 [N=213,179]	72 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, ≥1:60 [N=210,173]	27 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, ≥1:40 [N=210,173]	48 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, ≥1:80 [N=210,173]	4 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, ≥1:40 [N=213,179]	54 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 7, ≥1:60 [N=213,179]	51 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, ≥1:60 [N=210,173]	36 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 0, ≥1:40 [N=210,173]	10 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 7, ≥1:60 [N=213,179]	52 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria, Day 0, ≥1:80 [N=210,173]	27 Subjects
Fluarix Quadrivalent Unprimed Group	Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2, Day 0, ≥1:80 [N=210,173]	36 Subjects

Secondary

Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=107, 109]	189.4 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=106, 109]	293.9 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=106,106]	17.4 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=106,106]	34.6 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=106,109]	90.6 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=107,106]	38.4 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=106, 106]	25.3 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=106,109]	222.0 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=106,109]	40.6 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=106,106]	24.1 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=106, 109]	41.3 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=107,106]	58.8 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=107, 109]	114.2 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=106,106]	14.3 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=106,109]	27.6 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=106, 106]	15.4 Titer

Secondary

Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0[N=99,86]	34.8 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7[N=99,89]	287.1 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0[N=100,86]	35.0 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7[N=100,89]	175.8 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0[N=99,86]	16.8 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7[N=99,89]	89.2 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0[N=99,86]	25.1 Titer
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7[N=100,89]	216.5 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7[N=100,89]	39.7 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0[N=99,86]	23.5 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0[N=99,86]	15.0 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7[N=99,89]	38.3 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0[N=99,86]	15.4 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0[N=100,86]	45.9 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7[N=99,89]	29.1 Titer
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7[N=100,89]	84.5 Titer

Secondary

Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata

Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7,17-29M[N=53,54]	246.3 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 0,30-48M[N=54,54]	42.4 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 0,30-48M[N=53,54]	22.8 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 0,17-29M[N=53,52]	20.5 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 0,17-29M[N=53,52]	21.6 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 0,30-48M[N=53,54]	55.5 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7,30-48M[N=53,55]	350.7 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 0,17-29M[N=53,52]	34.7 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,17-29M[N=53,54]	158.0 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,30-48M[N=54,55]	226.4 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 0,17-29M[N=53,52]	13.2 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,17-29M[N=53,54]	68.8 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,30-48M[N=53,55]	119.2 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,17-29M[N=53,54]	181.4 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 0,30-48M[N=53,54]	31.1 Titers
Fluarix Quadrivalent Primed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,30-48M[N=53,55]	271.8 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,30-48M[N=53,55]	35.9 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7,17-29M[N=53,54]	22.9 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 7,30-48M[N=53,55]	73.7 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,17-29M[N=53,54]	85.3 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 0,30-48M[N=54,54]	69.0 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 7,30-48M[N=54,55]	152.2 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 0,17-29M[N=53,52]	13.2 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 0,30-48M[N=53,54]	15.7 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 0,30-48M[N=53,54]	17.9 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 0,17-29M[N=53,52]	13.1 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 0,17-29M[N=53,52]	15.8 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,17-29M[N=53,54]	29.3 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H1N1, Day 0,30-48M[N=53,54]	36.1 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Victoria, Day 7,17-29M[N=53,54]	21.1 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	Yamagata, Day 7,30-48M[N=53,55]	55.8 Titers
Fluarix Quadrivalent Unprimed Group	Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata	H3N2, Day 0,17-29M[N=53,52]	49.8 Titers

Secondary

Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1,Day 0[N=90,72]	141.4 Titer
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1,Day 7[N=100,76]	1461.3 Titer
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2,Day 0[N=92,76]	60.0 Titer
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2,Day 7[N=97,80]	374.6 Titer
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria,Day 0[N=100,89]	37.1 Titer
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria,Day 7[N=100,88]	189.9 Titer
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata,day 0[N=100,87]	37.1 Titer
Fluarix Quadrivalent Primed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7[N=100,88]	177.5 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata, Day 7[N=100,88]	49.8 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1,Day 0[N=90,72]	47.3 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria,Day 0[N=100,89]	23.5 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H1N1,Day 7[N=100,76]	138.4 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Yamagata,day 0[N=100,87]	30.9 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2,Day 0[N=92,76]	59.6 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	Victoria,Day 7[N=100,88]	52.0 Titer
Fluarix Quadrivalent Unprimed Group	Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.	H3N2,Day 7[N=97,80]	177.7 Titer

Secondary

Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=107,109]	38.6 Titer
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=107, 96]	1500.9 Titer
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=107, 108]	193.7 Titer
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=97,90]	138.2 Titer
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=107,107]	36.9 Titer
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=99,96]	66.5 Titer
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=107,107]	182.7 Titer
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=104,100]	422.9 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 7 [N=107,107]	51.7 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 7 [N=104,100]	325.1 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 0 [N=97,90]	48.3 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H1N1, Day 7 [N=107, 96]	139.4 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	H3N2, Day 0 [N=99,96]	82.8 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 0 [N=107,109]	22.2 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Victoria, Day 7 [N=107, 108]	47.0 Titer
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine	Yamagata, Day 0 [N=107,107]	30.8 Titer

Secondary

Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.

Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.

Time frame: At Day 0 and Day 7

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 0,17-29M[N=53,53]	35.6 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 0,30-48M[N=50,49]	76.0 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 0,30-48M[N=50,46]	240.0 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 7,30-48M[N=53,50]	480.3 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 0,17-29M[N=47,44]	76.8 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 0,17-29M[N=53,54]	29.2 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,30-48M[N=54,48]	2014.5 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 7,17-29M[N=53,53]	156.3 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7,30-48M[N=54,55]	212.2 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 0,30-48M[N=54,55]	50.9 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 0,17-29M[N=49,47]	58.1 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 7,30-48M[N=54,55]	239.1 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,17-29M [N=53,48]	1112.0 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7,17-29M[N=53,52]	156.9 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 0,30-48M[N=54,54]	38.3 Titers
Fluarix Quadrivalent Primed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 7,17-29M[N=51,50]	370.5 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 0,30-48M[N=54,54]	32.0 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7,17-29M[N=53,52]	45.6 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 7,30-48M[N=54,55]	58.3 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 0,17-29M[N=47,44]	29.0 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,17-29M [N=53,48]	53.0 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 0,30-48M[N=50,46]	78.8 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H1N1, Day 7,30-48M[N=54,48]	366.9 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 0,17-29M[N=49,47]	74.5 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 7,17-29M[N=51,50]	217.5 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 0,30-48M[N=50,49]	91.5 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	H3N2,Day 7,30-48M[N=53,50]	485.8 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 0,17-29M[N=53,54]	19.8 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 7,17-29M[N=53,53]	35.5 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 0,30-48M[N=54,55]	24.7 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Yamagata, Day 0,17-29M[N=53,53]	29.6 Titers
Fluarix Quadrivalent Unprimed Group	Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.	Victoria,Day 7,30-48M[N=54,55]	61.8 Titers

Secondary

Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	H1N1, Day 7[N=98,86]	70 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	H3N2, Day 7[N=100,86]	70 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	Victoria, Day 7[N=98,86]	74 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	Yamagata, Day 7[N=99,86]	85 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	Yamagata, Day 7[N=99,86]	23 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	H1N1, Day 7[N=98,86]	23 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	Victoria, Day 7[N=98,86]	20 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.	H3N2, Day 7[N=100,86]	22 Subjects

Secondary

Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.

VRR was defined as the number of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	Yamagata [N=105,106]	90 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	H3N2 [N=107,106]	75 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	H1N1 [N=105,106]	75 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	Victoria [N=105,106]	79 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	H1N1 [N=105,106]	31 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	Yamagata [N=105,106]	29 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	Victoria [N=105,106]	24 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.	H3N2 [N=107,106]	31 Subjects

Secondary

Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.

VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Victoria, Day 7,17-29M[N=53,52]	40 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H3N2, Day 7,17-29M[N=53,52]	36 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Victoria, Day 7,30-48M[N=52,54]	39 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H1N1, Day 7,30-48M[N=52,54]	32 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Yamagata, Day 7, 17-29M[N=53,52]	46 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H3N2, Day 7,30-48M[N=54,54]	39 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Yamagata, Day 7, 30-48M[N=52,54]	44 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H1N1, Day 7,17-29M[N=53,52]	43 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Yamagata, Day 7, 30-48M[N=52,54]	19 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H1N1, Day 7,30-48M[N=52,54]	20 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H3N2, Day 7,17-29M[N=53,52]	8 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H3N2, Day 7,30-48M[N=54,54]	23 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Victoria, Day 7,17-29M[N=53,52]	8 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Victoria, Day 7,30-48M[N=52,54]	16 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	Yamagata, Day 7, 17-29M[N=53,52]	10 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.	H1N1, Day 7,17-29M[N=53,52]	11 Subjects

Secondary

Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	H3N2 [N=97,94]	72 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	H1N1 [N=97,89]	74 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	Victoria [N=107,108]	78 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	Yamagata [N=107,105]	45 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	Yamagata [N=107,105]	15 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	H3N2 [N=97,94]	48 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	Victoria [N=107,108]	24 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.	H1N1 [N=97,89]	36 Subjects

Secondary

Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains

Time frame: At Day 7 post dose 1

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	H1N1, Day 7[N=90,71]	67 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	H3N2, Day 7[N=90,74]	66 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	Victoria, Day 7[N=100,88]	74 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	Yamagata, Day 7[N=100,86]	42 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	Yamagata, Day 7[N=100,86]	11 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	H1N1, Day 7[N=90,71]	28 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	Victoria, Day 7[N=100,88]	21 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains	H3N2, Day 7[N=90,74]	31 Subjects

Secondary

Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata

VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.

Time frame: At Day 7 post dose 1

Population: Analyses were perfomed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available

Arm	Measure	Group	Value (NUMBER)
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H3N2, Day 7,17-29M[N=48,46]	36 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Victoria, Day 7,17-29M[N=53,53]	41 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H3N2, Day 7,30-48M[N=49,48]	36 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Victoria, Day 7,30-48M[N=54,55]	37 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H1N1, Day 7, 30-48M[50,45]	35 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Yamagata, Day 7,17-29M[N=53,51]	17 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Yamagata, Day 7,30-48M[N=54,54]	28 Subjects
Fluarix Quadrivalent Primed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H1N1, Day 7, 17-29M[47,44]	39 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Yamagata, Day 7,30-48M[N=54,54]	9 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H3N2, Day 7,30-48M[N=49,48]	29 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Yamagata, Day 7,17-29M[N=53,51]	6 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H1N1, Day 7, 17-29M[47,44]	12 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H1N1, Day 7, 30-48M[50,45]	24 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Victoria, Day 7,17-29M[N=53,53]	9 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	Victoria, Day 7,30-48M[N=54,55]	15 Subjects
Fluarix Quadrivalent Unprimed Group	Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata	H3N2, Day 7,17-29M[N=48,46]	19 Subjects

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine

Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Duration of Solicted Symptoms

MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.

MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata

Number of Subjects Reporting AEs With Medically Attended Visits (MAV)

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.

Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)

Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata

Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.

Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine

Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.

Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.

Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.

Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.

Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.

Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains

Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata