Trial Outcomes & Findings for Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old (NCT NCT00464672)

NCT ID: NCT00464672

Last Updated: 2015-10-01

Results Overview

To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1893 participants
• Primary outcome timeframe: 21 days after vaccination
• Results posted on: 2015-10-01

Participant Flow

Approximately 6 weeks for enrollment with date of first enrolment on April 2007

All enrolled subjects were included in the trial.

Participant milestones

Measure	Influenza Virus Vaccine (18 to 64 Years) One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (18 to 64 Years) One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (9 to 17 Years) One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (9 to 17 Years) One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (3 to 8 Years) Two injections of the investigational influenza virus vaccine were administered intramuscularly	Comparator Influenza Vaccine (3 to 8 Years) Two injections of the comparator influenza vaccine were administered intramuscularly
Overall Study STARTED	460	232	400	200	402	199
Overall Study COMPLETED	435	222	400	199	392	195
Overall Study NOT COMPLETED	25	10	0	1	10	4

Reasons for withdrawal

Measure	Influenza Virus Vaccine (18 to 64 Years) One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (18 to 64 Years) One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (9 to 17 Years) One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (9 to 17 Years) One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (3 to 8 Years) Two injections of the investigational influenza virus vaccine were administered intramuscularly	Comparator Influenza Vaccine (3 to 8 Years) Two injections of the comparator influenza vaccine were administered intramuscularly
Overall Study withdrawal of consent	0	0	0	1	9	4
Overall Study Lost to Follow-up	25	10	0	0	1	0

Baseline Characteristics

Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

Baseline characteristics by cohort

Measure	Influenza Virus Vaccine n=1262 Participants Injections of the investigational influenza virus vaccine were administered intramuscularly	Comparator Influenza Vaccine n=631 Participants Injections of the comparator influenza vaccine were administered intramuscularly	Total n=1893 Participants Total of all reporting groups
Age, Continuous Chilren 3 to 8 years of age	5.5 years STANDARD_DEVIATION 1.7 • n=5 Participants	5.4 years STANDARD_DEVIATION 1.7 • n=7 Participants	5.5 years STANDARD_DEVIATION 1.7 • n=5 Participants
Age, Continuous Children/Adolescents 9 to 17 years of age	12.7 years STANDARD_DEVIATION 2.6 • n=5 Participants	12.8 years STANDARD_DEVIATION 2.6 • n=7 Participants	12.7 years STANDARD_DEVIATION 2.6 • n=5 Participants
Age, Continuous Adults 18 to 64 years of age	38.8 years STANDARD_DEVIATION 14.4 • n=5 Participants	37.8 years STANDARD_DEVIATION 12.6 • n=7 Participants	38.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex/Gender, Customized Male	575 participants n=5 Participants	294 participants n=7 Participants	869 participants n=5 Participants
Sex/Gender, Customized Female	687 participants n=5 Participants	337 participants n=7 Participants	1024 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	1168 participants n=5 Participants	579 participants n=7 Participants	1747 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	92 participants n=5 Participants	52 participants n=7 Participants	144 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP) population.

To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age	93 Percentages of participants Interval 90.0 to 95.0	96 Percentages of participants Interval 94.0 to 98.0	91 Percentages of participants Interval 87.0 to 93.0	99 Percentages of participants Interval 97.0 to 100.0	100 Percentages of participants Interval 98.0 to 100.0	86 Percentages of participants Interval 81.0 to 91.0

PRIMARY outcome

Timeframe: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP) population.

Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age	74 Percentage of participants Interval 69.0 to 78.0	72 Percentage of participants Interval 68.0 to 76.0	77 Percentage of participants Interval 72.0 to 81.0	86 Percentage of participants Interval 81.0 to 90.0	89 Percentage of participants Interval 84.0 to 92.0	74 Percentage of participants Interval 68.0 to 80.0

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The analysis was performed on the safety population.

Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=460 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=233 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) One injection of the comparator influenza vaccine was administered intramuscularly
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Sweating	24 participants	11 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Any local reaction	161 participants	89 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Erythema	27 participants	12 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Induration	38 participants	24 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Swelling	29 participants	15 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Ecchymosis	24 participants	15 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Pain	117 participants	70 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Any Systemic Reaction	147 participants	84 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Chills	21 participants	17 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Malaise	55 participants	27 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Myalgia	66 participants	37 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Arthralgia	30 participants	14 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Headache	108 participants	42 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Fatigue	46 participants	24 participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age Fever	10 participants	6 participants	—	—	—	—

SECONDARY outcome

Timeframe: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP) population.

To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age	99 Percentage of subjects Interval 97.0 to 100.0	100 Percentage of subjects Interval 99.0 to 100.0	93 Percentage of subjects Interval 90.0 to 95.0	98 Percentage of subjects Interval 96.0 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	89 Percentage of subjects Interval 84.0 to 93.0

SECONDARY outcome

Timeframe: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP)population.

Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age	92 Percentage of participants Interval 88.0 to 94.0	67 Percentage of participants Interval 62.0 to 72.0	81 Percentage of participants Interval 76.0 to 84.0	91 Percentage of participants Interval 86.0 to 94.0	92 Percentage of participants Interval 87.0 to 95.0	73 Percentage of participants Interval 67.0 to 80.0

SECONDARY outcome

Timeframe: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP)population

To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=393 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=192 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age	960 Titers Interval 857.0 to 1076.0	493 Titers Interval 453.0 to 536.0	144 Titers Interval 127.0 to 163.0	1246 Titers Interval 1058.0 to 1467.0	1463 Titers Interval 1296.0 to 1651.0	114 Titers Interval 95.0 to 136.0

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The analysis was performed on the safety population.

Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=400 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=199 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) One injection of the comparator influenza vaccine was administered intramuscularly
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Any local reaction	134 Participants	62 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Erythema	7 Participants	3 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Induration	28 Participants	13 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Swelling	28 Participants	14 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Ecchymosis	9 Participants	1 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Pain	117 Participants	58 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Any Systemic reaction	91 Participants	49 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Chills	18 Participants	11 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Malaise	18 Participants	8 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Myalgia	35 Participants	25 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Arthralgia	11 Participants	5 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Headache	52 Participants	22 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Sweating	4 Participants	3 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Fatigue	25 Participants	9 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age Fever	1 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 50 days after last vaccination

Population: The analysis was performed on the per-protocol (PP) population

To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age	97 Percentage of participants Interval 94.0 to 99.0	100 Percentage of participants Interval 99.0 to 100.0	85 Percentage of participants Interval 80.0 to 89.0	99 Percentage of participants Interval 95.0 to 100.0	99 Percentage of participants Interval 96.0 to 100.0	81 Percentage of participants Interval 73.0 to 87.0

SECONDARY outcome

Timeframe: 50 days after last vaccination

Population: The analysis was performed on the per protocol (PP) population.

Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age	95 Percentage of participants Interval 91.0 to 97.0	86 Percentage of participants Interval 82.0 to 90.0	83 Percentage of participants Interval 78.0 to 87.0	97 Percentage of participants Interval 92.0 to 99.0	95 Percentage of participants Interval 90.0 to 98.0	79 Percentage of participants Interval 72.0 to 85.0

SECONDARY outcome

Timeframe: 50 days after last vaccination

Population: The analysis was performed on the per-protocol (PP)population.

To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=296 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=149 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age	625 Titers Interval 532.0 to 734.0	710 Titers Interval 637.0 to 792.0	157 Titers Interval 133.0 to 185.0	716 Titers Interval 570.0 to 898.0	1472 Titers Interval 1263.0 to 1715.0	126 Titers Interval 100.0 to 158.0

SECONDARY outcome

Timeframe: 7 days after each vaccination

Population: The analysis was performed on the safety population.

Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=402 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=199 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=396 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=197 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) One injection of the comparator influenza vaccine was administered intramuscularly
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Any Local Reaction	92 Participants	56 Participants	66 Participants	39 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Erythema	9 Participants	5 Participants	3 Participants	3 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Induration	11 Participants	10 Participants	13 Participants	8 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Swelling	22 Participants	16 Participants	13 Participants	8 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Ecchymosis	18 Participants	9 Participants	10 Participants	5 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Pain	68 Participants	40 Participants	57 Participants	35 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Any Systemic Reaction	66 Participants	38 Participants	41 Participants	21 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Chills	10 Participants	8 Participants	8 Participants	5 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Malaise	21 Participants	12 Participants	19 Participants	7 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Myalgia	19 Participants	9 Participants	19 Participants	10 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Arthralgia	5 Participants	2 Participants	5 Participants	1 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Headache	28 Participants	18 Participants	15 Participants	11 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Sweating	5 Participants	3 Participants	3 Participants	1 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Fatigue	18 Participants	9 Participants	10 Participants	4 Participants	—	—
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. Fever	12 Participants	3 Participants	10 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: 21 days after vaccination

Population: The analysis was done on the per protocol population

Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.

Outcome measures

Measure	Influenza Virus Vaccine (A/H1N1) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (A/H3N2) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Influenza Virus Vaccine (Strain B) n=424 Participants One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H1N1) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (A/H3N2) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly	Comparator Influenza Vaccine (Strain B) n=219 Participants One injection of the comparator influenza vaccine was administered intramuscularly
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age	244 Titers Interval 214.0 to 278.0	219 Titers Interval 196.0 to 245.0	126 Titers Interval 113.0 to 140.0	512 Titers Interval 426.0 to 615.0	485 Titers Interval 415.0 to 567.0	104 Titers Interval 90.0 to 122.0

Adverse Events

Influenza Virus Vaccine (18 to 64 Years)

Serious events: 6 serious events

Other events: 235 other events

Deaths: 0 deaths

Comparator Influenza Vaccine (18 to 64 Years)

Serious events: 2 serious events

Other events: 128 other events

Deaths: 0 deaths

Influenza Virus Vaccine (9 to 17 Years)

Serious events: 4 serious events

Other events: 167 other events

Deaths: 0 deaths

Comparator Influenza Vaccine (9 to 17 Years)

Serious events: 0 serious events

Other events: 80 other events

Deaths: 0 deaths

Influenza Virus Vaccine (3 to 8 Years)

Serious events: 3 serious events

Other events: 153 other events

Deaths: 0 deaths

Comparator Influenza Vaccine (3 to 8 Years)

Serious events: 3 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Measure	Influenza Virus Vaccine (18 to 64 Years) n=460 participants at risk One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (18 to 64 Years) n=233 participants at risk One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (9 to 17 Years) n=400 participants at risk One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (9 to 17 Years) n=199 participants at risk One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (3 to 8 Years) n=402 participants at risk Two injections of the investigational influenza virus vaccine were administered intramuscularly	Comparator Influenza Vaccine (3 to 8 Years) n=199 participants at risk Two injections of the comparator influenza vaccine were administered intramuscularly
Eye disorders Visual acuity reduced transiently	0.22% 1/460 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Gastrointestinal disorders Gastritis	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.43% 1/233 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Infections and infestations appendicitis	0.22% 1/460 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.50% 2/400 • Number of events 2 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Infections and infestations diverticulitis	0.22% 1/460 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Infections and infestations dysentery	0.22% 1/460 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ovarian epithelial cancer	0.22% 1/460 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Nervous system disorders syncope	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.43% 1/233 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Pregnancy, puerperium and perinatal conditions abortion spontaneous	0.22% 1/460 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Gastrointestinal disorders vomiting	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.25% 1/400 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.50% 1/199 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Renal and urinary disorders renal colic	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.25% 1/400 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Infections and infestations pneumonia	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.50% 1/199 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Infections and infestations urinary tract infection	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.25% 1/402 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Injury, poisoning and procedural complications eye injury	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.25% 1/402 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Nervous system disorders encephalitis	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/402 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.50% 1/199 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Respiratory, thoracic and mediastinal disorders asthmatic crisis	0.00% 0/460 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/233 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/400 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.25% 1/402 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.00% 0/199 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.

Other adverse events

Measure	Influenza Virus Vaccine (18 to 64 Years) n=460 participants at risk One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (18 to 64 Years) n=233 participants at risk One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (9 to 17 Years) n=400 participants at risk One injection of the investigational influenza virus vaccine was administered intramuscularly	Comparator Influenza Vaccine (9 to 17 Years) n=199 participants at risk One injection of the comparator influenza vaccine was administered intramuscularly	Influenza Virus Vaccine (3 to 8 Years) n=402 participants at risk Two injections of the investigational influenza virus vaccine were administered intramuscularly	Comparator Influenza Vaccine (3 to 8 Years) n=199 participants at risk Two injections of the comparator influenza vaccine were administered intramuscularly
General disorders Chills	4.8% 22/460 • Number of events 25 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	7.7% 18/233 • Number of events 20 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	4.5% 18/400 • Number of events 24 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	5.5% 11/199 • Number of events 11 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	4.5% 18/402 • Number of events 19 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.0% 12/199 • Number of events 14 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
General disorders Fatigue	10.2% 47/460 • Number of events 51 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	10.3% 24/233 • Number of events 26 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.2% 25/400 • Number of events 25 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	4.5% 9/199 • Number of events 9 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.5% 26/402 • Number of events 28 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.0% 12/199 • Number of events 14 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
General disorders Injection Site Erythema	5.9% 27/460 • Number of events 27 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	5.2% 12/233 • Number of events 12 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	1.8% 7/400 • Number of events 7 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	1.5% 3/199 • Number of events 3 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	3.0% 12/402 • Number of events 12 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	3.5% 7/199 • Number of events 8 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
General disorders Injection Site Haemorrhage	5.4% 25/460 • Number of events 25 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.4% 15/233 • Number of events 15 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	2.2% 9/400 • Number of events 9 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	0.50% 1/199 • Number of events 1 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.5% 26/402 • Number of events 28 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.5% 13/199 • Number of events 14 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
General disorders Injection Site Induration	8.3% 38/460 • Number of events 38 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	10.3% 24/233 • Number of events 24 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	7.0% 28/400 • Number of events 28 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.5% 13/199 • Number of events 13 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	5.7% 23/402 • Number of events 24 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	8.0% 16/199 • Number of events 18 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
General disorders Injection Site Pain	25.4% 117/460 • Number of events 121 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	30.0% 70/233 • Number of events 70 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	29.2% 117/400 • Number of events 120 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	29.1% 58/199 • Number of events 58 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	24.1% 97/402 • Number of events 129 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	29.6% 59/199 • Number of events 75 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
General disorders Injection Site Swelling	6.3% 29/460 • Number of events 29 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.4% 15/233 • Number of events 15 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	7.0% 28/400 • Number of events 28 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	7.0% 14/199 • Number of events 14 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	8.5% 34/402 • Number of events 37 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	10.1% 20/199 • Number of events 24 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
General disorders Malaise	12.2% 56/460 • Number of events 61 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	12.0% 28/233 • Number of events 29 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	4.5% 18/400 • Number of events 18 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	4.0% 8/199 • Number of events 8 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	9.2% 37/402 • Number of events 41 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	9.5% 19/199 • Number of events 19 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 32/460 • Number of events 38 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	6.4% 15/233 • Number of events 16 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	2.8% 11/400 • Number of events 11 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	2.5% 5/199 • Number of events 5 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	2.5% 10/402 • Number of events 12 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	1.5% 3/199 • Number of events 3 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 66/460 • Number of events 74 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	16.3% 38/233 • Number of events 39 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	8.8% 35/400 • Number of events 36 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	12.6% 25/199 • Number of events 26 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	8.5% 34/402 • Number of events 41 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	8.5% 17/199 • Number of events 19 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Nervous system disorders Headache	24.1% 111/460 • Number of events 133 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	19.3% 45/233 • Number of events 54 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	13.0% 52/400 • Number of events 56 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	11.6% 23/199 • Number of events 29 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	10.2% 41/402 • Number of events 46 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	13.1% 26/199 • Number of events 30 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.2% 24/460 • Number of events 26 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	4.7% 11/233 • Number of events 14 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	1.0% 4/400 • Number of events 4 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	1.5% 3/199 • Number of events 3 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	2.0% 8/402 • Number of events 8 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.	2.0% 4/199 • Number of events 4 • Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216). One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.

Additional Information

Novartis Vaccines and Diagnostics

Novartis Vaccines and Diagnostics

Email: RegContactVacUS.nvdit@Novartis.com

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Restriction type: LTE60