Trial Outcomes & Findings for Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age (NCT NCT01857206)

NCT ID: NCT01857206

Last Updated: 2014-12-05

Results Overview

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2055 participants
• Primary outcome timeframe: Day 1 to Day 7 after any vaccination
• Results posted on: 2014-12-05

Participant Flow

Subjects were enrolled at a total of 34 centers in 5 countries: 18 sites in the US, 6 sites in Australia, 2 sites in New Zealand, 5 sites in the Philippines and 3 sites in Thailand.

Participant milestones

Measure	TIVc Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Overall Study STARTED	1372	683
Overall Study COMPLETED	1359	673
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Measure	TIVc Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Overall Study ADMINISTRATIVE REASON	0	1
Overall Study Lost to Follow-up	9	6
Overall Study Unclassified	3	3
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Baseline characteristics by cohort

Measure	TIVc n=1372 Participants Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf n=683 Participants Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	TOTAL n=2055 Participants Total of all reporting groups
Age, Continuous	9.1 year STANDARD_DEVIATION 3.8 • n=5 Participants	9.3 year STANDARD_DEVIATION 3.9 • n=7 Participants	9.1 year STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	703 Participants n=5 Participants	349 Participants n=7 Participants	1052 Participants n=5 Participants
Sex: Female, Male Male	669 Participants n=5 Participants	334 Participants n=7 Participants	1003 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7 after any vaccination

Population: Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.

Outcome measures

Measure	TIVc (≥4 to ≤8 Years) n=688 Participants Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf (≥4 to ≤8 Years) n=341 Participants Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	TIVc (≥9 to ≤17 Years) n=682 Participants Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf (≥9 to ≤17 Years) n=341 Participants Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Injection site Ecchymosis (AE)	68 Subjects	30 Subjects	27 Subjects	11 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Any Local	422 Subjects	202 Subjects	370 Subjects	160 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Injection site Induration (AE)	109 Subjects	43 Subjects	46 Subjects	33 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Injection site Swelling (AE)	87 Subjects	37 Subjects	36 Subjects	26 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Injection site Erythema (AE)	148 Subjects	57 Subjects	72 Subjects	37 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Injection site Pain (AE)	384 Subjects	186 Subjects	356 Subjects	142 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Any Systemic	252 Subjects	110 Subjects	267 Subjects	113 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Chills (AE)	47 Subjects	17 Subjects	39 Subjects	7 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Nausea (AE)	57 Subjects	26 Subjects	45 Subjects	16 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Myalgia (AE)	113 Subjects	41 Subjects	126 Subjects	44 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Arthralgia (AE)	39 Subjects	16 Subjects	54 Subjects	14 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Headache (AE)	105 Subjects	42 Subjects	128 Subjects	57 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Fatigue (AE)	92 Subjects	34 Subjects	109 Subjects	56 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Loss of appetite (AE)	68 Subjects	25 Subjects	50 Subjects	12 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Malaise (AE)	112 Subjects	43 Subjects	99 Subjects	46 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Sweating (AE)	39 Subjects	20 Subjects	52 Subjects	23 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Body Temperature (≥38°C) (AE)	48 Subjects	30 Subjects	12 Subjects	5 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. ≥40°C (Other Indicator)	3 Subjects	0 Subjects	0 Subjects	0 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Prevention of pain and/or fever (Other Indicator)	61 Subjects	29 Subjects	24 Subjects	10 Subjects
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. Treatment of pain and/or fever (Other Indicator)	90 Subjects	40 Subjects	39 Subjects	18 Subjects

PRIMARY outcome

Timeframe: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.

Population: Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.

Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.

Outcome measures

Measure	TIVc (≥4 to ≤8 Years) n=688 Participants Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf (≥4 to ≤8 Years) n=340 Participants Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	TIVc (≥9 to ≤17 Years) n=681 Participants Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf (≥9 to ≤17 Years) n=341 Participants Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Any AE	277 Subjects	139 Subjects	158 Subjects	88 Subjects
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. At least possibly related AE	50 Subjects	26 Subjects	32 Subjects	22 Subjects

PRIMARY outcome

Timeframe: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

Population: Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.

Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.

Outcome measures

Measure	TIVc (≥4 to ≤8 Years) n=688 Participants Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf (≥4 to ≤8 Years) n=340 Participants Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	TIVc (≥9 to ≤17 Years) n=681 Participants Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf (≥9 to ≤17 Years) n=341 Participants Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. Death	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. SAE	17 Subjects	7 Subjects	7 Subjects	9 Subjects
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. At least possibly related SAE	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. AE leading to withdrawal	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. Medically attended AE	284 Subjects	139 Subjects	172 Subjects	105 Subjects
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. NOCD	5 Subjects	4 Subjects	3 Subjects	1 Subjects

Adverse Events

TIVc(4-8Years )

Serious events: 17 serious events

Other events: 545 other events

Deaths: 0 deaths

TIVf(4-8Years )

Serious events: 7 serious events

Other events: 267 other events

Deaths: 0 deaths

TIVc(9-17Years )

Serious events: 7 serious events

Other events: 489 other events

Deaths: 0 deaths

TIVf(9-17Years )

Serious events: 9 serious events

Other events: 220 other events

Deaths: 0 deaths

Serious adverse events

Measure	TIVc(4-8Years ) n=688 participants at risk Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf(4-8Years ) n=341 participants at risk Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	TIVc(9-17Years ) n=682 participants at risk Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf(9-17Years ) n=341 participants at risk Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Blood and lymphatic system disorders LYMPHADENITIS	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.15% 1/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.15% 1/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations ACUTE SINUSITIS	0.29% 2/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations APPENDICITIS PERFORATED	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations BRONCHITIS	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations CELLULITIS	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations DENGUE FEVER	0.29% 2/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.15% 1/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.88% 3/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations GASTROENTERITIS	0.29% 2/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations NASOPHARYNGITIS	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations PHARYNGITIS	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations PHARYNGOTONSILLITIS	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations PNEUMONIA	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.15% 1/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations SINUSITIS BACTERIAL	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations URINARY TRACT INFECTION	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations WOUND INFECTION	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Injury, poisoning and procedural complications ANIMAL BITE	0.44% 3/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.88% 3/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Injury, poisoning and procedural complications ANIMAL SCRATCH	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.15% 1/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.15% 1/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Injury, poisoning and procedural complications INJURY	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Injury, poisoning and procedural complications MULTIPLE INJURIES	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.15% 1/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Nervous system disorders CEREBELLAR ATAXIA	0.15% 1/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Nervous system disorders VISUAL FIELD DEFECT	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Reproductive system and breast disorders ADNEXAL TORSION	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.29% 1/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	0.00% 0/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183

Other adverse events

Measure	TIVc(4-8Years ) n=688 participants at risk Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf(4-8Years ) n=341 participants at risk Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	TIVc(9-17Years ) n=682 participants at risk Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	TIVf(9-17Years ) n=341 participants at risk Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Gastrointestinal disorders NAUSEA	8.9% 61/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	7.9% 27/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	6.6% 45/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	5.0% 17/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders CHILLS	7.0% 48/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	5.3% 18/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	5.7% 39/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	2.3% 8/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders FATIGUE	13.8% 95/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	10.6% 36/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	16.0% 109/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	16.4% 56/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders INJECTION SITE ERYTHEMA	23.8% 164/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	19.9% 68/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	12.5% 85/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	12.6% 43/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders INJECTION SITE HAEMORRHAGE	10.0% 69/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	8.8% 30/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	4.0% 27/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	3.2% 11/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders INJECTION SITE INDURATION	16.6% 114/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	13.2% 45/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	7.0% 48/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	9.7% 33/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders INJECTION SITE PAIN	62.9% 433/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	61.9% 211/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	56.5% 385/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	46.6% 159/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders INJECTION SITE SWELLING	13.8% 95/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	12.6% 43/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	6.0% 41/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	8.5% 29/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders MALAISE	16.3% 112/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	12.6% 43/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	14.5% 99/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	13.5% 46/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
General disorders PYREXIA	9.2% 63/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	12.3% 42/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	2.5% 17/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	2.6% 9/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations NASOPHARYNGITIS	5.2% 36/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	5.0% 17/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	3.1% 21/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	4.4% 15/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	19.3% 133/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	17.6% 60/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	8.5% 58/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	7.6% 26/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Infections and infestations VIRAL INFECTION	5.1% 35/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	4.1% 14/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	2.1% 14/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	2.3% 8/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Metabolism and nutrition disorders DECREASED APPETITE	9.9% 68/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	7.3% 25/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	7.5% 51/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	3.5% 12/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Musculoskeletal and connective tissue disorders ARTHRALGIA	6.0% 41/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	4.7% 16/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	8.4% 57/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	4.4% 15/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Musculoskeletal and connective tissue disorders MYALGIA	16.7% 115/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	12.0% 41/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	19.1% 130/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	13.2% 45/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Nervous system disorders HEADACHE	15.7% 108/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	12.9% 44/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	20.1% 137/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	18.2% 62/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183
Skin and subcutaneous tissue disorders HYPERHIDROSIS	5.7% 39/688 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	5.9% 20/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	7.6% 52/682 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183	6.7% 23/341 • 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated. For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60