Trial Outcomes & Findings for A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications (NCT NCT01998477)

NCT ID: NCT01998477

Last Updated: 2017-04-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

430 participants

Primary outcome timeframe

Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2

Results posted on

2017-04-21

Participant Flow

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

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	TIVc (3 to <18 Years) Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV (3 to <18 Years) Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
Overall Study STARTED	282	148
Overall Study COMPLETED	272	143
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	TIVc (3 to <18 Years) Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV (3 to <18 Years) Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
Overall Study Lost to Follow-up	4	5
Overall Study Withdrawal by Subject	6	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIVc (3 to <18 Years) n=282 Participants Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV (3 to <18 Years) n=148 Participants Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	Total n=430 Participants Total of all reporting groups
Age, Continuous	8.7 year STANDARD_DEVIATION 4.0 • n=5 Participants	9.0 year STANDARD_DEVIATION 3.9 • n=7 Participants	8.8 year STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male FEMALE	121 Participants n=5 Participants	63 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male MALE	161 Participants n=5 Participants	85 Participants n=7 Participants	246 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2

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

Outcome measures

Outcome measures
Measure	TIVc _inj 1 (3 to <18 Years) n=277 Participants Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_inj 2 (3 to <18 Years) n=83 Participants Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_inj 1 (3 to <18 Years) n=145 Participants Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_inj 2 (3 to <18 Years) n=40 Participants Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_naive_inj 1 (3 to <6 Years) Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_naive_inj 2 (3 to <6 Years) Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years) Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_Naive_inj 1 (≥ 6 to < 9 Years) Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_Naive_inj 2 (≥ 6 to < 9 Years) Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_Non Naive_inj 1 (≥ 6 to < 9 Years) Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_Naive_inj 1 (≥ 6 to < 9 Years) Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_Naive_inj 2 (≥ 6 to < 9 Years) Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIVc_Non Naive (9 to <18 Years) Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_Non Naive (9 to <18 Years) Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Prevention of pain and or fever	19 Subjects	2 Subjects	9 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Any Local	149 Subjects	41 Subjects	89 Subjects	18 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection Site Tenderness	25 Subjects	20 Subjects	17 Subjects	6 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection Site Pain	106 Subjects	19 Subjects	65 Subjects	8 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection site erythema ,< 6 years	8 Subjects	3 Subjects	4 Subjects	4 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection site induration < 6 years	7 Subjects	5 Subjects	4 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection site ecchymosis < 6 years	6 Subjects	1 Subjects	3 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection site erythema >=6 years	16 Subjects	5 Subjects	22 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection site induration >=6years	22 Subjects	3 Subjects	23 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Injection site ecchymosis >= 6 years	8 Subjects	2 Subjects	5 Subjects	5 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Any Systemic	117 Subjects	29 Subjects	55 Subjects	8 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Change in eating habits	12 Subjects	6 Subjects	7 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Chills	32 Subjects	6 Subjects	9 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Diarrhea	19 Subjects	2 Subjects	5 Subjects	3 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Irritability	14 Subjects	5 Subjects	7 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Sleepiness	10 Subjects	5 Subjects	3 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Vomiting	18 Subjects	3 Subjects	5 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Arthralgia	24 Subjects	0 Subjects	9 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Fatigue	28 Subjects	4 Subjects	16 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Headache	35 Subjects	8 Subjects	24 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Loss of appetite	30 Subjects	5 Subjects	16 Subjects	2 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Myalgia	35 Subjects	5 Subjects	14 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Nausea	21 Subjects	0 Subjects	12 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Body Temp. ( >= 38C )	18 Subjects	2 Subjects	6 Subjects	0 Subjects	—	—	—	—	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group Treatment of pain and or fever	28 Subjects	7 Subjects	11 Subjects	1 Subjects	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 7 after any vaccination

Population: Analysis was done on safety dataset

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

Outcome measures

Outcome measures
Measure	TIVc _inj 1 (3 to <18 Years) n=28 Participants Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_inj 2 (3 to <18 Years) n=50 Participants Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_inj 1 (3 to <18 Years) n=50 Participants Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_inj 2 (3 to <18 Years) n=19 Participants Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_naive_inj 1 (3 to <6 Years) n=15 Participants Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_naive_inj 2 (3 to <6 Years) n=15 Participants Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years) n=26 Participants Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_Naive_inj 1 (≥ 6 to < 9 Years) n=35 Participants Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_Naive_inj 2 (≥ 6 to < 9 Years) n=33 Participants Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_Non Naive_inj 1 (≥ 6 to < 9 Years) n=16 Participants Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_Naive_inj 1 (≥ 6 to < 9 Years) n=23 Participants Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_Naive_inj 2 (≥ 6 to < 9 Years) n=24 Participants Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIVc_Non Naive (9 to <18 Years) n=138 Participants Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_Non Naive (9 to <18 Years) n=72 Participants Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Body Temp. ( >= 38C )	4 Subjects	8 Subjects	2 Subjects	3 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects	3 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Any Local	14 Subjects	19 Subjects	22 Subjects	12 Subjects	7 Subjects	7 Subjects	16 Subjects	19 Subjects	19 Subjects	8 Subjects	13 Subjects	11 Subjects	81 Subjects	49 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	3 Subjects	0 Subjects	2 Subjects	0 Subjects	0 Subjects	17 Subjects	10 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Treatment of pain and or fever	6 Subjects	9 Subjects	3 Subjects	3 Subjects	0 Subjects	1 Subjects	0 Subjects	4 Subjects	4 Subjects	0 Subjects	2 Subjects	0 Subjects	9 Subjects	6 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)	10 Subjects	15 Subjects	20 Subjects	11 Subjects	6 Subjects	6 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72)	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	15 Subjects	18 Subjects	19 Subjects	8 Subjects	10 Subjects	8 Subjects	73 Subjects	47 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61	7 Subjects	1 Subjects	3 Subjects	4 Subjects	0 Subjects	4 Subjects	1 Subjects	3 Subjects	5 Subjects	4 Subjects	5 Subjects	3 Subjects	5 Subjects	2 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Injection site induration	2 Subjects	5 Subjects	5 Subjects	2 Subjects	2 Subjects	3 Subjects	1 Subjects	4 Subjects	3 Subjects	3 Subjects	2 Subjects	3 Subjects	6 Subjects	7 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Injection site ecchymosis	2 Subjects	4 Subjects	1 Subjects	2 Subjects	1 Subjects	3 Subjects	2 Subjects	3 Subjects	2 Subjects	0 Subjects	3 Subjects	5 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Any Systemic	10 Subjects	22 Subjects	14 Subjects	9 Subjects	5 Subjects	5 Subjects	9 Subjects	18 Subjects	15 Subjects	5 Subjects	5 Subjects	3 Subjects	58 Subjects	31 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Change in eating habits	5 Subjects	7 Subjects	6 Subjects	3 Subjects	4 Subjects	2 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72	2 Subjects	5 Subjects	3 Subjects	2 Subjects	0 Subjects	0 Subjects	3 Subjects	3 Subjects	3 Subjects	1 Subjects	0 Subjects	0 Subjects	19 Subjects	6 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71	3 Subjects	1 Subjects	1 Subjects	1 Subjects	0 Subjects	2 Subjects	1 Subjects	3 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects	11 Subjects	4 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Irritability	6 Subjects	8 Subjects	5 Subjects	5 Subjects	2 Subjects	2 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)	4 Subjects	6 Subjects	5 Subjects	3 Subjects	0 Subjects	2 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72	3 Subjects	4 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	3 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	8 Subjects	3 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	4 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	18 Subjects	7 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	3 Subjects	4 Subjects	2 Subjects	0 Subjects	0 Subjects	23 Subjects	14 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	5 Subjects	8 Subjects	3 Subjects	2 Subjects	1 Subjects	29 Subjects	19 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects	8 Subjects	5 Subjects	2 Subjects	2 Subjects	2 Subjects	20 Subjects	12 Subjects
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects	2 Subjects	5 Subjects	2 Subjects	1 Subjects	0 Subjects	29 Subjects	11 Subjects

PRIMARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	TIVc _inj 1 (3 to <18 Years) n=278 Participants Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_inj 2 (3 to <18 Years) n=148 Participants Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_inj 1 (3 to <18 Years) n=85 Participants Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_inj 2 (3 to <18 Years) n=54 Participants Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_naive_inj 1 (3 to <6 Years) n=139 Participants Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_naive_inj 2 (3 to <6 Years) n=39 Participants Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years) n=35 Participants Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_Naive_inj 1 (≥ 6 to < 9 Years) n=74 Participants Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIVc_Naive_inj 2 (≥ 6 to < 9 Years) Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_Non Naive_inj 1 (≥ 6 to < 9 Years) Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_Naive_inj 1 (≥ 6 to < 9 Years) Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIV_Naive_inj 2 (≥ 6 to < 9 Years) Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)	TIVc_Non Naive (9 to <18 Years) Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)	TIV_Non Naive (9 to <18 Years) Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata Any AEs	213 Subjects	111 Subjects	77 Subjects	46 Subjects	90 Subjects	32 Subjects	29 Subjects	50 Subjects	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata Any possibly related AEs	17 Subjects	12 Subjects	7 Subjects	3 Subjects	7 Subjects	5 Subjects	3 Subjects	4 Subjects	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata SAEs	12 Subjects	4 Subjects	4 Subjects	2 Subjects	6 Subjects	0 Subjects	2 Subjects	2 Subjects	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata Medically Attended AEs	187 Subjects	94 Subjects	71 Subjects	38 Subjects	78 Subjects	28 Subjects	24 Subjects	42 Subjects	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata Deaths	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata AEs leading to vaccine/study withdrawal	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata Possibly or probably related SAE	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata AEs leading to NOCD	3 Subjects	1 Subjects	1 Subjects	0 Subjects	2 Subjects	0 Subjects	1 Subjects	0 Subjects	—	—	—	—	—	—

Adverse Events

TIVc (3 to <18 Years)

Serious events: 12 serious events

Other events: 246 other events

Deaths: 0 deaths

TIV (3 to <18 Years)

Serious events: 4 serious events

Other events: 126 other events

Deaths: 0 deaths

Total

Serious events: 16 serious events

Other events: 372 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER