Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age. (NCT NCT02914275)

Last Updated: 2019-01-23

Results Overview

Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV. B/VIC = B/Victoria B/YAM = B/Yamagata

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2250 participants

Primary outcome timeframe

Postvaccination (28 days after last vaccination)

Results posted on

2019-01-23

Participant Flow

Subjects were enrolled from 27 September 2016 to 11 August 2017 from 39 study sites in the United States of America.

A total of 2339 subjects were screened. A total of 2250 subjects were randomized to study treatment. Due to not having valid informed consent, 3 subjects were removed from the clinical database. Therefore, overall 2247 subjects gave informed consent and were included in the analysis set.

Participant milestones

Participant milestones
Measure	Seqirus QIV Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Overall Study STARTED	1687	563
Overall Study Included in Clinical Database / FAS	1684	563
Overall Study COMPLETED	1566	521
Overall Study NOT COMPLETED	121	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Seqirus QIV Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Overall Study Lost to Follow-up	84	29
Overall Study Withdrawal by Subject	26	10
Overall Study Protocol Violation	1	1
Overall Study Physician Decision	3	1
Overall Study Other	4	1
Overall Study Excluded due to invalid informed consent	3	0

Baseline Characteristics

A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seqirus QIV n=1684 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=563 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Total n=2247 Participants Total of all reporting groups
Age, Continuous	36.6 months STANDARD_DEVIATION 14.70 • n=5 Participants	36.5 months STANDARD_DEVIATION 14.68 • n=7 Participants	36.6 months STANDARD_DEVIATION 14.69 • n=5 Participants
Age, Customized 6 through 35 months	700 Participants n=5 Participants	235 Participants n=7 Participants	935 Participants n=5 Participants
Age, Customized 36 through 59 months	984 Participants n=5 Participants	328 Participants n=7 Participants	1312 Participants n=5 Participants
Sex: Female, Male Female	820 Participants n=5 Participants	268 Participants n=7 Participants	1088 Participants n=5 Participants
Sex: Female, Male Male	864 Participants n=5 Participants	295 Participants n=7 Participants	1159 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	434 Participants n=5 Participants	160 Participants n=7 Participants	594 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1243 Participants n=5 Participants	400 Participants n=7 Participants	1643 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Black or African American	361 Participants n=5 Participants	123 Participants n=7 Participants	484 Participants n=5 Participants
Race (NIH/OMB) White	1205 Participants n=5 Participants	391 Participants n=7 Participants	1596 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	85 Participants n=5 Participants	34 Participants n=7 Participants	119 Participants n=5 Participants
Region of Enrollment United States	1684 Participants n=5 Participants	563 Participants n=7 Participants	2247 Participants n=5 Participants
Weight	15.36 kilograms STANDARD_DEVIATION 4.224 • n=5 Participants	15.40 kilograms STANDARD_DEVIATION 4.149 • n=7 Participants	15.37 kilograms STANDARD_DEVIATION 4.205 • n=5 Participants
Prevaccination Axillary Temperature	97.17 °F STANDARD_DEVIATION 0.963 • n=5 Participants	97.25 °F STANDARD_DEVIATION 0.935 • n=7 Participants	97.19 °F STANDARD_DEVIATION 0.936 • n=5 Participants
Vaccination against influenza 2015/2016 season	845 Participants n=5 Participants	294 Participants n=7 Participants	1139 Participants n=5 Participants

PRIMARY outcome

Timeframe: Postvaccination (28 days after last vaccination)

Population: The Per-Protocol Population (PPS) comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.

Outcome measures

Outcome measures
Measure	Seqirus QIV n=1456 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=484 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. A/H1N1	370.0 Geometric Mean Titer Interval 345.13 to 396.55	311.7 Geometric Mean Titer Interval 276.88 to 350.9	—	—
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. A/H3N2	436.8 Geometric Mean Titer Interval 403.04 to 473.28	589.1 Geometric Mean Titer Interval 516.42 to 671.91	—	—
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. B/YAM	25.5 Geometric Mean Titer Interval 23.93 to 27.06	29.7 Geometric Mean Titer Interval 26.51 to 33.21	—	—
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. B/VIC	56.8 Geometric Mean Titer Interval 52.9 to 60.96	57.9 Geometric Mean Titer Interval 51.04 to 65.62	—	—

PRIMARY outcome

Timeframe: Postvaccination (28 days after last vaccination)

Population: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.

Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. SCR is defined as the percentage of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each vaccine (for each strain) will be determined.

Outcome measures

Outcome measures
Measure	Seqirus QIV n=1456 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=484 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
The Difference in Seroconversion Rate (SCR) for Each Virus Strain. A/H1N1	79.1 Percentage of participants Interval 76.9 to 81.1	68.8 Percentage of participants Interval 64.5 to 72.9	—	—
The Difference in Seroconversion Rate (SCR) for Each Virus Strain. A/H3N2	82.3 Percentage of participants Interval 80.2 to 84.2	84.9 Percentage of participants Interval 81.4 to 88.0	—	—
The Difference in Seroconversion Rate (SCR) for Each Virus Strain. B/YAM	38.9 Percentage of participants Interval 36.4 to 41.4	41.9 Percentage of participants Interval 37.5 to 46.5	—	—
The Difference in Seroconversion Rate (SCR) for Each Virus Strain. B/VIC	60.2 Percentage of participants Interval 57.6 to 62.7	61.1 Percentage of participants Interval 56.6 to 65.4	—	—

SECONDARY outcome

Timeframe: Postvaccination (up to 7 days after vaccination)

Population: The Solicited Safety Population comprises all subjects in the Full Analysis Set (FAS) who received at least one dose or partial dose of Study Vaccine and had provided any evaluable data on solicited events.

Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose

Outcome measures

Outcome measures
Measure	Seqirus QIV n=1618 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=545 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Solicited AEs, Any	940 Participants	312 Participants	—	—
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Solicited AEs, Grade 1	592 Participants	189 Participants	—	—
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Solicited AEs, Grade 2	277 Participants	83 Participants	—	—
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Solicited AEs, Grade 3	71 Participants	39 Participants	—	—
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Solicited AEs, Local	645 Participants	208 Participants	—	—
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Solicited AEs, Systemic	633 Participants	215 Participants	—	—

SECONDARY outcome

Timeframe: Postvaccination (up to 28 days after each vaccination)

Population: The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and had provided any evaluable data on solicited events.

Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose

Outcome measures

Outcome measures
Measure	Seqirus QIV n=1618 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=545 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Number of Participants With Cellulitis-like Reactions	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Postvaccination (up to 28 days after vaccination)

Population: The Overall Safety Population was used for the analysis of overall and unsolicited adverse event safety and comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and have provided any evaluable follow-up safety data.

Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose

Outcome measures

Outcome measures
Measure	Seqirus QIV n=1673 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=559 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Number of Participants With Unsolicited AEs Unsolicited AEs, Any	536 Participants	171 Participants	—	—
Number of Participants With Unsolicited AEs Unsolicited AEs, Grade 1	285 Participants	92 Participants	—	—
Number of Participants With Unsolicited AEs Unsolicited AEs, Grade 2	206 Participants	65 Participants	—	—
Number of Participants With Unsolicited AEs Unsolicited AEs, Grade 3	45 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: 180 days after the last vaccination dose.

Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest

Outcome measures

Outcome measures
Measure	Seqirus QIV n=1673 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=559 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Number of Participants With Serious Adverse Events (SAE) SAEs (Day 1 to Day 28)	4 Participants	0 Participants	—	—
Number of Participants With Serious Adverse Events (SAE) SAEs (Day 29 to Final Database Lock)	7 Participants	3 Participants	—	—
Number of Participants With Serious Adverse Events (SAE) Related SAEs	0 Participants	0 Participants	—	—
Number of Participants With Serious Adverse Events (SAE) Deaths	0 Participants	0 Participants	—	—
Number of Participants With Serious Adverse Events (SAE) AESIs (Day 1 to Day 28)	0 Participants	0 Participants	—	—
Number of Participants With Serious Adverse Events (SAE) AESIs (Day 29 to Final Database Lock)	2 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 28 days after last vaccination.

The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate geometric mean of HI titers prevaccination \& postvaccination.

Outcome measures

Outcome measures
Measure	Seqirus QIV n=586 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=870 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A n=193 Participants Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B n=291 Participants Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain A/H1N1, Prevaccination	13.8 Titers Interval 12.3 to 15.57	60.7 Titers Interval 53.97 to 68.2	14.9 Titers Interval 12.25 to 18.22	68.7 Titers Interval 55.84 to 84.62
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain A/H1N1, Postvaccination	184.9 Titers Interval 165.15 to 207.05	590.2 Titers Interval 548.62 to 634.93	168.3 Titers Interval 137.69 to 205.62	469.2 Titers Interval 413.72 to 532.05
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain A/H3N2, Prevaccination	14.3 Titers Interval 12.48 to 16.39	62.4 Titers Interval 55.5 to 70.19	16.4 Titers Interval 12.86 to 20.91	65.5 Titers Interval 53.76 to 79.88
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain A/H3N2, Postvaccination	184.9 Titers Interval 164.57 to 207.65	778.6 Titers Interval 710.83 to 852.82	247.5 Titers Interval 202.14 to 302.95	1047 Titers Interval 911.69 to 1202.48
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain B/YAM, Prevaccination	5.9 Titers Interval 5.66 to 6.13	7.9 Titers Interval 7.55 to 8.33	5.8 Titers Interval 5.47 to 6.22	8.3 Titers Interval 7.58 to 9.17
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain B/YAM, Postvaccination	15.6 Titers Interval 14.33 to 17.0	35.4 Titers Interval 32.73 to 38.26	16.3 Titers Interval 14.03 to 18.95	44.1 Titers Interval 38.3 to 50.87
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain B/VIC, Prevaccination	7.1 Titers Interval 6.75 to 7.55	9.6 Titers Interval 9.04 to 10.19	6.9 Titers Interval 6.26 to 7.53	10.4 Titers Interval 9.35 to 11.64
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain B/VIC, Postvaccination	39.8 Titers Interval 36.02 to 44.04	72.1 Titers Interval 65.62 to 79.25	31.9 Titers Interval 26.88 to 37.81	85.9 Titers Interval 73.16 to 100.96

SECONDARY outcome

Timeframe: 28 days after last vaccination

The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer.

Outcome measures

Outcome measures
Measure	Seqirus QIV n=586 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=870 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A n=193 Participants Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B n=291 Participants Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Seroconversion Rates (SCRs) of Each Virus Strain A/H1N1	81.9 Percentage of participants Interval 78.6 to 84.9	77.1 Percentage of participants Interval 74.2 to 79.9	80.3 Percentage of participants Interval 74.0 to 85.7	61.2 Percentage of participants Interval 55.3 to 66.8
Seroconversion Rates (SCRs) of Each Virus Strain A/H3N2	82.4 Percentage of participants Interval 79.1 to 85.4	82.2 Percentage of participants Interval 79.5 to 84.7	85.0 Percentage of participants Interval 79.1 to 89.7	84.9 Percentage of participants Interval 80.2 to 88.8
Seroconversion Rates (SCRs) of Each Virus Strain B/YAM	22.5 Percentage of participants Interval 19.2 to 26.1	49.9 Percentage of participants Interval 46.5 to 53.3	26.9 Percentage of participants Interval 20.8 to 33.8	51.9 Percentage of participants Interval 46.0 to 57.8
Seroconversion Rates (SCRs) of Each Virus Strain B/VIC	52.9 Percentage of participants Interval 48.8 to 57.0	65.1 Percentage of participants Interval 61.8 to 68.2	49.7 Percentage of participants Interval 42.5 to 57.0	68.6 Percentage of participants Interval 62.9 to 73.9

SECONDARY outcome

Timeframe: 28 days after last vaccination.

The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Study Exit Visit.

Outcome measures

Outcome measures
Measure	Seqirus QIV n=586 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=870 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A n=193 Participants Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B n=291 Participants Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Seroprotection Rates of Each Virus Strain A/H1N1	90.1 Percentage of participants Interval 87.4 to 92.4	99.1 Percentage of participants Interval 98.2 to 99.6	88.6 Percentage of participants Interval 83.3 to 92.7	98.3 Percentage of participants Interval 96.0 to 99.4
Seroprotection Rates of Each Virus Strain A/H3N2	92.5 Percentage of participants Interval 90.0 to 94.5	98.4 Percentage of participants Interval 97.3 to 99.1	95.3 Percentage of participants Interval 91.3 to 97.8	98.6 Percentage of participants Interval 96.5 to 99.6
Seroprotection Rates of Each Virus Strain B/YAM	24.7 Percentage of participants Interval 21.3 to 28.4	57.1 Percentage of participants Interval 53.8 to 60.4	29.0 Percentage of participants Interval 22.7 to 36.0	61.5 Percentage of participants Interval 55.7 to 67.1
Seroprotection Rates of Each Virus Strain B/VIC	55.6 Percentage of participants Interval 51.5 to 59.7	71.0 Percentage of participants Interval 67.9 to 74.0	52.8 Percentage of participants Interval 45.6 to 60.1	75.3 Percentage of participants Interval 69.9 to 80.1

SECONDARY outcome

Timeframe: Prevaccination (Day 1) and Postvaccination (28 days after last vaccination)

The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer change (rise) from Day 1 to Study Exit Visit.

Outcome measures

Outcome measures
Measure	Seqirus QIV n=586 Participants Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=870 Participants Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort A n=193 Participants Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV Cohort B n=291 Participants Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Geometric Mean Fold Increase (GMFI) of Each Virus Strain A/H1N1	13.4 Fold Change Interval 11.98 to 14.9	9.7 Fold Change Interval 8.9 to 10.64	11.3 Fold Change Interval 9.4 to 13.49	6.8 Fold Change Interval 5.83 to 7.99
Geometric Mean Fold Increase (GMFI) of Each Virus Strain A/H3N2	13.0 Fold Change Interval 11.62 to 14.5	12.5 Fold Change Interval 11.42 to 13.62	15.1 Fold Change Interval 12.6 to 18.08	16.0 Fold Change Interval 13.62 to 18.74
Geometric Mean Fold Increase (GMFI) of Each Virus Strain B/YAM	2.6 Fold Change Interval 2.45 to 2.86	4.5 Fold Change Interval 4.17 to 4.77	2.8 Fold Change Interval 2.45 to 3.19	5.3 Fold Change Interval 4.67 to 6.0
Geometric Mean Fold Increase (GMFI) of Each Virus Strain B/VIC	5.6 Fold Change Interval 5.11 to 6.09	7.5 Fold Change Interval 6.93 to 8.15	4.6 Fold Change Interval 3.97 to 5.42	8.2 Fold Change Interval 7.18 to 9.42

Adverse Events

Seqirus QIV

Serious events: 11 serious events

Other events: 320 other events

Deaths: 0 deaths

Comparator QIV

Serious events: 3 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Seqirus QIV n=1673 participants at risk Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=559 participants at risk Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Infections and infestations Croup Infectious	0.12% 2/1673 • Number of events 2 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Infections and infestations Bronchiolitis	0.00% 0/1673 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.18% 1/559 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Infections and infestations Pneumonia respiratory syncytial viral	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Infections and infestations Respiratory syncytial virus bronchiolitis	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Infections and infestations Respiratory syncytial virus infection	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Metabolism and nutrition disorders Dehydration	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Nervous system disorders Febrile convulsion	0.12% 2/1673 • Number of events 2 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Gastrointestinal disorders Dysphagia	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/1673 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.18% 1/559 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Injury, poisoning and procedural complications Animal bite	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Injury, poisoning and procedural complications Foreign body aspiration	0.06% 1/1673 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.00% 0/559 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1673 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	0.18% 1/559 • Number of events 1 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559

Other adverse events

Other adverse events
Measure	Seqirus QIV n=1673 participants at risk Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.	Comparator QIV n=559 participants at risk Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 153/1673 • Number of events 167 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	7.3% 41/559 • Number of events 52 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.0% 134/1673 • Number of events 155 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	9.5% 53/559 • Number of events 63 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Infections and infestations Pyrexia	5.4% 91/1673 • Number of events 100 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	4.5% 25/559 • Number of events 29 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559
Infections and infestations Upper respiratory tract infection	4.0% 67/1673 • Number of events 72 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559	3.0% 17/559 • Number of events 17 • Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180 Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population. Seqirus QIV N = 1673 Comparator QIV N = 559

Additional Information

Clinical Study Disclosure Manager

Seqirus

Phone: 1-855-358-8966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Seqirus agreements and restrictions on publishing may vary with individual investigators; however, Seqirus will not prohibit any investigator from publishing. Seqirus supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER