Trial Outcomes & Findings for Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age (NCT NCT01209780)

NCT ID: NCT01209780

Last Updated: 2014-03-11

Results Overview

The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination. Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer \<1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3116 participants

Primary outcome timeframe

Day 22 for non-naive/Day 50 for naive subjects

Results posted on

2014-03-11

Participant Flow

The study was conducted in 13 centers across 4 countries: Mexico, Colombia, Panama and Philippines.

Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis. The population was analyzed in the enrolled set.

Participant milestones

Participant milestones
Measure	TIV (3-8 Years Old) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (4-8 Years) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.	Control (3 to < 4 Years) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.	TIV (9-17 Years) All subjects in this group were non-naive and received one dose of investigational TIV.	Control (9-17 Years) All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
Overall Study STARTED	1042	485	48	817	412
Overall Study COMPLETED	1016	467	44	807	407
Overall Study NOT COMPLETED	26	18	4	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	TIV (3-8 Years Old) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (4-8 Years) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.	Control (3 to < 4 Years) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.	TIV (9-17 Years) All subjects in this group were non-naive and received one dose of investigational TIV.	Control (9-17 Years) All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
Overall Study Adverse Event	0	1	0	0	0
Overall Study Withdrawal by Subject	9	2	1	1	0
Overall Study Lost to Follow-up	17	12	3	9	4
Overall Study Protocol Violation	0	1	0	0	0
Overall Study Inappropriate enrollment	0	2	0	0	1

Baseline Characteristics

Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIV (3-8 Years) n=1042 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=533 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine.	TIV (9-17 Years) n=817 Participants All subjects received one dose of investigational TIV.	Control (9-17 Years) n=412 Participants All subjects received one dose of control TIV (eTIV\_f).	Total n=2804 Participants Total of all reporting groups
Age, Continuous	5.6 years STANDARD_DEVIATION 1.6 • n=93 Participants	5.6 years STANDARD_DEVIATION 1.6 • n=4 Participants	12.4 years STANDARD_DEVIATION 2.4 • n=27 Participants	12.3 years STANDARD_DEVIATION 2.3 • n=483 Participants	8.6 years STANDARD_DEVIATION 3.9 • n=36 Participants
Sex: Female, Male Female	517 Participants n=93 Participants	269 Participants n=4 Participants	398 Participants n=27 Participants	215 Participants n=483 Participants	1399 Participants n=36 Participants
Sex: Female, Male Male	525 Participants n=93 Participants	264 Participants n=4 Participants	419 Participants n=27 Participants	197 Participants n=483 Participants	1405 Participants n=36 Participants

PRIMARY outcome

Timeframe: Day 22 for non-naive/Day 50 for naive subjects

Population: Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=918 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=468 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) All subjects received one dose of investigational TIV.	Control (9-17 Years) All subjects received one dose of control vaccine(TIVf).
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion H1N1 strain (N=916,467)	95 Percentages Interval 93.0 to 96.0	94 Percentages Interval 91.0 to 96.0	—	—
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion H3N2 strain (N=917,468)	78 Percentages Interval 75.0 to 80.0	87 Percentages Interval 84.0 to 90.0	—	—
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion B strain	87 Percentages Interval 84.0 to 89.0	85 Percentages Interval 82.0 to 89.0	—	—

PRIMARY outcome

Timeframe: Day 22 for non-naive/Day 50 for naive subjects

Population: Analysis was performed on the per protocol population.

The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=918 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=468 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) All subjects received one dose of investigational TIV.	Control (9-17 Years) All subjects received one dose of control vaccine(TIVf).
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) Baseline (H1N1 strain, N=917,467)	26 Titers Interval 22.0 to 31.0	28 Titers Interval 25.0 to 31.0	—	—
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) Day 22 or Day 50 (H1N1 strain,N=917,468)	1157 Titers Interval 1052.0 to 1272.0	1501 Titers Interval 1283.0 to 1756.0	—	—
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) Baseline (H3N2 strain)	142 Titers Interval 127.0 to 158.0	150 Titers Interval 129.0 to 175.0	—	—
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) Day 22 or Day 50 (H3N2 strain, N=917,468)	1385 Titers Interval 1300.0 to 1475.0	2032 Titers Interval 1843.0 to 2240.0	—	—
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) Baseline (B strain)	12 Titers Interval 11.0 to 13.0	13 Titers Interval 12.0 to 14.0	—	—
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) Day 22 or Day 50 (B strain)	208 Titers Interval 193.0 to 224.0	195 Titers Interval 174.0 to 217.0	—	—

SECONDARY outcome

Timeframe: Day 22 for non-naive/Day 50 for naive subjects

Population: Analysis was performed on per protocol population.

The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported. This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=918 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=468 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) All subjects received one dose of investigational TIV.	Control (9-17 Years) All subjects received one dose of control vaccine(TIVf).
Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine. Baseline (H1N1strain, N=917,467)	49 Percentages of subjects Interval 46.0 to 53.0	48 Percentages of subjects Interval 44.0 to 53.0	—	—
Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine. Day 22 or Day 50 (H1N1strain; N=917,468)	97 Percentages of subjects Interval 95.0 to 98.0	95 Percentages of subjects Interval 93.0 to 97.0	—	—
Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine. Baseline (H3N2 strain)	84 Percentages of subjects Interval 81.0 to 86.0	85 Percentages of subjects Interval 82.0 to 88.0	—	—
Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine. Day 22 or Day 50 (H3N2 strain; N=917,468)	100 Percentages of subjects Interval 100.0 to 100.0	100 Percentages of subjects Interval 99.0 to 100.0	—	—
Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine. Baseline (B strain)	23 Percentages of subjects Interval 21.0 to 26.0	26 Percentages of subjects Interval 22.0 to 30.0	—	—
Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine. Day 22 or Day 50 (B strain)	95 Percentages of subjects Interval 93.0 to 96.0	92 Percentages of subjects Interval 90.0 to 95.0	—	—

SECONDARY outcome

Timeframe: Day 22 for non-naive/Day 50 for naive

Population: Analysis was performed on the per protocol population.

The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported. This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=918 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=468 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) All subjects received one dose of investigational TIV.	Control (9-17 Years) All subjects received one dose of control vaccine(TIVf).
Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine H1N1 strain (N= 916,467)	95 Percentages of subjects Interval 93.0 to 96.0	94 Percentages of subjects Interval 91.0 to 96.0	—	—
Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine H3N2 strain ( N= 917,468)	78 Percentages of subjects Interval 75.0 to 80.0	87 Percentages of subjects Interval 84.0 to 90.0	—	—
Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine B strain	87 Percentages of subjects Interval 84.0 to 89.0	85 Percentages of subjects Interval 82.0 to 89.0	—	—

SECONDARY outcome

Timeframe: Day 1, Day 29, and Day 50

Population: Analysis was done on the per protocol population.

The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50). This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=820 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=413 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) All subjects received one dose of investigational TIV.	Control (9-17 Years) All subjects received one dose of control vaccine(TIVf).
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 1 (H1N1 strain, N=819,412)	49 Percentages of subjects Interval 46.0 to 53.0	48 Percentages of subjects Interval 43.0 to 53.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 29 (H1N1 strain, N=819,413)	83 Percentages of subjects Interval 80.0 to 86.0	82 Percentages of subjects Interval 78.0 to 86.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 50 (H1N1 strain, N= 819,413)	99 Percentages of subjects Interval 98.0 to 100.0	98 Percentages of subjects Interval 96.0 to 99.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 1 (H3N2 strain)	88 Percentages of subjects Interval 85.0 to 90.0	90 Percentages of subjects Interval 87.0 to 93.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 29 (H3N2 strain, N= 819, 413)	99 Percentages of subjects Interval 98.0 to 100.0	98 Percentages of subjects Interval 96.0 to 99.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 50 (H3N2 strain,N= 819, 413)	100 Percentages of subjects Interval 100.0 to 100.0	100 Percentages of subjects Interval 99.0 to 100.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 1 (B strain)	25 Percentages of subjects Interval 22.0 to 28.0	26 Percentages of subjects Interval 22.0 to 31.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 29 (B strain, N= 820,412)	82 Percentages of subjects Interval 79.0 to 84.0	81 Percentages of subjects Interval 77.0 to 85.0	—	—
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. Day 50 (B strain)	98 Percentages of subjects Interval 96.0 to 99.0	94 Percentages of subjects Interval 92.0 to 96.0	—	—

SECONDARY outcome

Timeframe: Day 29 and Day 50

Population: Analysis was done on the per protocol population.

The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50). This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=820 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=413 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) All subjects received one dose of investigational TIV.	Control (9-17 Years) All subjects received one dose of control vaccine(TIVf).
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine Day 29 (H3N2 strain, N= 819,413)	74 Percentages of subjects Interval 71.0 to 77.0	87 Percentages of subjects Interval 83.0 to 90.0	—	—
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine Day 50 (H3N2 strain, N= 819,413)	78 Percentages of subjects Interval 75.0 to 80.0	87 Percentages of subjects Interval 84.0 to 90.0	—	—
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine Day 29 (B strain, N= 820,412)	74 Percentages of subjects Interval 71.0 to 77.0	73 Percentages of subjects Interval 68.0 to 77.0	—	—
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine Day 50 (B strain)	89 Percentages of subjects Interval 87.0 to 91.0	88 Percentages of subjects Interval 85.0 to 91.0	—	—
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine Day 29 (H1N1 strain, N= 818,412)	82 Percentages of subjects Interval 79.0 to 84.0	81 Percentages of subjects Interval 77.0 to 85.0	—	—
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine Day 50 (H1N1 strain, N= 818,412)	98 Percentages of subjects Interval 96.0 to 99.0	96 Percentages of subjects Interval 94.0 to 98.0	—	—

SECONDARY outcome

Timeframe: Day 1 to 7 after vaccination

Population: Analysis was done on the safety set population i.e all subjects who received at least one study vaccine and provided post vaccination safety data.

The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=1037 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=531 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) n=817 Participants All subjects received one dose of investigational TIV.	Control (9-17 Years) n=412 Participants All subjects received one dose of control vaccine(TIVf).
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Any local	364 Subjects	216 Subjects	270 Subjects	148 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Injection site pain	363 Subjects	215 Subjects	268 Subjects	146 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Injection site ecchymosis	1 Subjects	1 Subjects	2 Subjects	0 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Injection site erythema	1 Subjects	1 Subjects	2 Subjects	1 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Injection site induration	10 Subjects	6 Subjects	5 Subjects	6 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Injection site swelling	11 Subjects	11 Subjects	6 Subjects	3 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Any systemic	262 Subjects	161 Subjects	193 Subjects	94 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Chills	37 Subjects	20 Subjects	38 Subjects	8 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Malaise	77 Subjects	51 Subjects	68 Subjects	27 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Myalgia	78 Subjects	50 Subjects	54 Subjects	34 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Arthralgia	41 Subjects	20 Subjects	26 Subjects	12 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Headache (N=1037,531,817,411)	101 Subjects	52 Subjects	93 Subjects	38 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Sweating	37 Subjects	29 Subjects	43 Subjects	22 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Fatigue	34 Subjects	22 Subjects	52 Subjects	21 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Fever (≥ 38°C)	116 Subjects	68 Subjects	39 Subjects	12 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Other	153 Subjects	89 Subjects	103 Subjects	54 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Analgesic/Antipyretic med.used(N=1032,531,816,412)	91 Subjects	52 Subjects	22 Subjects	9 Subjects
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Stayed at home due to reaction(N=1019,524,809,411)	93 Subjects	54 Subjects	89 Subjects	49 Subjects

SECONDARY outcome

Timeframe: Day 1 to 180 (non-naive )/Day 1 to 209 (naive)

Population: Analysis was done on the safety set population.

The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.

Outcome measures

Outcome measures
Measure	TIV (3-8 Years) n=1039 Participants The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=531 Participants The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) n=817 Participants All subjects received one dose of investigational TIV.	Control (9-17 Years) n=412 Participants All subjects received one dose of control vaccine(TIVf).
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Any adverse event	395 Subjects	194 Subjects	101 Subjects	58 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine At least possibly related adverse event	64 Subjects	36 Subjects	23 Subjects	11 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine At least possibly related serious adverse event	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine Serious adverse event	14 Subjects	3 Subjects	4 Subjects	3 Subjects

Adverse Events

TIV (3-8 Years)

Serious events: 14 serious events

Other events: 657 other events

Deaths: 0 deaths

Control (3-8 Years)

Serious events: 3 serious events

Other events: 342 other events

Deaths: 0 deaths

TIV (9-17 Years)

Serious events: 4 serious events

Other events: 385 other events

Deaths: 0 deaths

Control (9-17 Years)

Serious events: 3 serious events

Other events: 196 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	TIV (3-8 Years) n=1039 participants at risk The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.	Control (3-8 Years) n=531 participants at risk The group \[control (4-8 years) + control (3 to\<4 years)\] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-\<9 years) received TIVf and subjects (3-\<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.	TIV (9-17 Years) n=817 participants at risk All subjects received one dose of investigational TIV.	Control (9-17 Years) n=412 participants at risk All subjects received one dose of control vaccine (TIV\_f).
General disorders injection site pain	34.9% 363/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	40.5% 215/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	32.8% 268/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	35.4% 146/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
General disorders malaise	7.4% 77/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	9.8% 52/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	8.3% 68/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	6.6% 27/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
General disorders pyrexia	15.8% 164/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	17.1% 91/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	5.3% 43/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	3.6% 15/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
Infections and infestations nasopharingitis	8.2% 85/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	7.0% 37/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	0.00% 0/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	0.00% 0/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
Infections and infestations upper respiratory tract infection	9.8% 102/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	7.7% 41/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	0.00% 0/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	0.00% 0/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
General disorders fatigue	0.00% 0/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	0.00% 0/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	6.4% 52/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	5.1% 21/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
Musculoskeletal and connective tissue disorders myalgia	7.6% 79/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	9.6% 51/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	6.6% 54/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	8.3% 34/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
Nervous system disorders headache	10.2% 106/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	10.2% 54/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	11.5% 94/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	10.0% 41/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.
Skin and subcutaneous tissue disorders hyperhidrosis	3.6% 37/1039 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	5.5% 29/531 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	5.3% 43/817 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.	5.3% 22/412 • Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects. The population analyzed here is the safety set.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
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Restriction type: GT60