A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (TIVc) or in Embryonated Eggs (TIV), in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01998477

Enrollment

430

Registered

2013-11-29

Start date

2013-10-31

Completion date

2014-07-31

Last updated

2017-04-21

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

Conditions

Influenza

Keywords

Influenza, Vaccine, Flu, Children, Adolescents

Brief summary

The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to \< 18 years of age who are at risk of complications of influenza disease due to underlying diseases.

Interventions

BIOLOGICALTIVc

Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere

BIOLOGICALTIV

A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

* Individuals 3 to \<18 years of age with underlying medical conditions that indicate an increased risk of complications from influenza infection. * Further eligibility criteria may be discussed by contacting the site(s)

Exclusion criteria

* Individuals with any fatal prognosis of an underlying medical condition (\<12 month life expectancy). * Individuals hospitalized at the time of enrolment. * Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components. * Further eligibility criteria may be discussed by contacting the site(s)

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2	Safety was assessed in terms of number of the subjects (3 to \< 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Day 1 through Day 7 after any vaccination	Safety was assessed in terms of number of the subjects (3 to \<6 years,(≥ 6 to \< 9 years and 9 to \<18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)	Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to \<18 years) and age sub-strata (3 to \<9 years and 9 to \<18 years)

Countries

Italy, Spain

Participant flow

Recruitment details

Subjects were recruited from 12 centers in Spain and 4 centers from Italy.

Pre-assignment details

All enrolled subjects were included in the trial.

Participants by arm

Arm	Count
TIVc (3 to <18 Years) Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	282
TIV (3 to <18 Years) Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	148
Total	430

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	4	5
Overall Study	Withdrawal by Subject	6	0

Baseline characteristics

Characteristic	TIVc (3 to <18 Years)	TIV (3 to <18 Years)	Total
Age, Continuous	8.7 year STANDARD_DEVIATION 4	9.0 year STANDARD_DEVIATION 3.9	8.8 year STANDARD_DEVIATION 4
Sex: Female, Male FEMALE	121 Participants	63 Participants	184 Participants
Sex: Female, Male MALE	161 Participants	85 Participants	246 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	246 / 278	126 / 148	372 / 426
serious Total, serious adverse events	12 / 278	4 / 148	16 / 426

Outcome results

Primary

Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata

Safety was assessed in terms of number of the subjects (3 to \<6 years,(≥ 6 to \< 9 years and 9 to \<18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV

Time frame: Day 1 through Day 7 after any vaccination

Population: Analysis was done on safety dataset

Arm	Measure	Group	Value (NUMBER)
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	6 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	7 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	2 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	10 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	5 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	2 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	3 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	4 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	14 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	6 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	10 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	2 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	3 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	4 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	19 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	1 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	8 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	8 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	22 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	15 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	4 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	7 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	9 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	4 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	1 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	6 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	14 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	6 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	20 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	1 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	2 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	5 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	22 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	3 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	3 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	3 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	5 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	5 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	1 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	2 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	1 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	5 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	9 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	1 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	11 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	12 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	4 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	2 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	6 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	2 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	7 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	1 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	5 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	4 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	1 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	7 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	3 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	2 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	2 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	3 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	4 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	2 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	6 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	1 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	5 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	2 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	16 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	15 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	1 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	1 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	2 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	9 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	3 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	1 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	2 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	2 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	1 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	2 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	4 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	1 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	1 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	5 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	18 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	3 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	8 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	18 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	3 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	19 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	3 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	3 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	3 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	3 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	4 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	2 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	4 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	4 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	3 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	1 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	19 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	3 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	3 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	4 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	8 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	1 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	19 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	15 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	1 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	5 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	5 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	2 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	4 Subjects
TIVc_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	5 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	2 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	3 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	1 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	3 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	4 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	2 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	2 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	1 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	2 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	1 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	5 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	8 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	8 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	5 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	1 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	3 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	2 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	2 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	5 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	2 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	10 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	2 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	1 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	0 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	13 Subjects
TIV_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	3 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	2 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	3 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	5 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	1 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	11 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	8 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	3 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	0 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	1 Subjects
TIV_Naive_inj 2 (≥ 6 to < 9 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	81 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	18 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	4 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	19 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	29 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	20 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	6 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	5 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	29 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	23 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	0 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	8 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	58 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	17 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	73 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	11 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIVc_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	9 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	12 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	7 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	47 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	4 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Treatment of pain and or fever	6 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Irritability	0 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	11 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site ecchymosis	0 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	3 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	0 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	10 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Systemic	31 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	14 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Any Local	49 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	6 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Body Temp. ( >= 38C )	3 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Change in eating habits	0 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	19 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	2 Subjects
TIV_Non Naive (9 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Injection site induration	7 Subjects

Primary

Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group

Safety was assessed in terms of number of the subjects (3 to \< 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV

Time frame: Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2

Population: Analysis was done on safety dataset, i.e. the subjects in the Exposed Set who provided post-vaccination solicited AE data

Arm	Measure	Group	Value (NUMBER)
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Local	149 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Prevention of pain and or fever	19 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Fatigue	28 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration >=6years	22 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Arthralgia	24 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Pain	106 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Nausea	21 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis >= 6 years	8 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Sleepiness	10 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration < 6 years	7 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Irritability	14 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Systemic	117 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Treatment of pain and or fever	28 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Tenderness	25 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Myalgia	35 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Change in eating habits	12 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis < 6 years	6 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Vomiting	18 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Headache	35 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Chills	32 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Body Temp. ( >= 38C )	18 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema ,< 6 years	8 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Loss of appetite	30 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Diarrhea	19 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema >=6 years	16 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Diarrhea	2 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Headache	8 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Irritability	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Sleepiness	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Fatigue	4 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Vomiting	3 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Arthralgia	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration < 6 years	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Tenderness	20 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Body Temp. ( >= 38C )	2 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis < 6 years	1 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Local	41 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema >=6 years	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Nausea	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration >=6years	3 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis >= 6 years	2 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Pain	19 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Myalgia	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Systemic	29 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Prevention of pain and or fever	2 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Change in eating habits	6 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Treatment of pain and or fever	7 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Loss of appetite	5 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Chills	6 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema ,< 6 years	3 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Vomiting	5 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Local	89 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Tenderness	17 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Pain	65 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema ,< 6 years	4 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration < 6 years	4 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis < 6 years	3 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema >=6 years	22 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration >=6years	23 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis >= 6 years	5 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Systemic	55 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Change in eating habits	7 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Chills	9 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Diarrhea	5 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Irritability	7 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Sleepiness	3 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Arthralgia	9 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Fatigue	16 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Headache	24 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Loss of appetite	16 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Myalgia	14 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Nausea	12 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Body Temp. ( >= 38C )	6 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Treatment of pain and or fever	11 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Prevention of pain and or fever	9 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Headache	1 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Chills	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Change in eating habits	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Prevention of pain and or fever	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Loss of appetite	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Systemic	8 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis >= 6 years	5 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Treatment of pain and or fever	1 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Myalgia	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration >=6years	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema >=6 years	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Tenderness	6 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Nausea	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site ecchymosis < 6 years	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site induration < 6 years	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Any Local	18 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Body Temp. ( >= 38C )	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Arthralgia	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Vomiting	1 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Sleepiness	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection site erythema ,< 6 years	4 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Fatigue	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Irritability	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Diarrhea	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Injection Site Pain	8 Subjects

Primary

Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata

Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to \<18 years) and age sub-strata (3 to \<9 years and 9 to \<18 years)

Time frame: Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)

Population: Analysis was done on unsolicited safety dataset, i.e. all subjects in the Exposed Set who have post-vaccination unsolicited AE records (even if no AEs have occurred)

Arm	Measure	Group	Value (NUMBER)
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	12 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	213 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	3 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	187 Subjects
TIVc _inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	17 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	111 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	94 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	4 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	1 Subjects
TIVc_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	12 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	77 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	1 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	7 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	71 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	4 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIV_inj 1 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	3 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	0 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	46 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	38 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	2 Subjects
TIV_inj 2 (3 to <18 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	6 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	7 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	2 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	78 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects
TIV_naive_inj 1 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	90 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	28 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	32 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	5 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIV_naive_inj 2 (3 to <6 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	24 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	1 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	29 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	3 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	2 Subjects
TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Deaths	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to NOCD	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	SAEs	2 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Medically Attended AEs	42 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Possibly or probably related SAE	0 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any AEs	50 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Any possibly related AEs	4 Subjects
TIVc_Naive_inj 1 (≥ 6 to < 9 Years)	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	AEs leading to vaccine/study withdrawal	0 Subjects

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026

A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

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Brief summary

Related papers

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Study design

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Design outcomes

Primary

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Participant flow

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Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata

Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group

Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata