Trial Outcomes & Findings for Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects (NCT NCT04074928)

Results Overview

The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2414 participants

Primary outcome timeframe

Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects

Results posted on

2022-01-12

Participant Flow

Subjects were enrolled in the 2019/2020 Northern Hemisphere influenza season from 47 centers in the United States.

In total, 2414 subjects were enrolled in the study.

Participant milestones

Participant milestones
Measure	QIVc Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Overall Study STARTED	1605	809
Overall Study Received Study Vaccine	1597	805
Overall Study COMPLETED	1370	710
Overall Study NOT COMPLETED	235	99

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QIVc n=1597 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=805 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Total n=2402 Participants Total of all reporting groups
Age, Categorical <=18 years	1597 Participants n=93 Participants	805 Participants n=4 Participants	2402 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	28.1 months STANDARD_DEVIATION 11.54 • n=93 Participants	28.2 months STANDARD_DEVIATION 11.63 • n=4 Participants	28.1 months STANDARD_DEVIATION 11.57 • n=27 Participants
Sex: Female, Male Female	794 Participants n=93 Participants	399 Participants n=4 Participants	1193 Participants n=27 Participants
Sex: Female, Male Male	803 Participants n=93 Participants	406 Participants n=4 Participants	1209 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	434 Participants n=93 Participants	226 Participants n=4 Participants	660 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1160 Participants n=93 Participants	575 Participants n=4 Participants	1735 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized Asian	13 Participants n=93 Participants	8 Participants n=4 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	455 Participants n=93 Participants	209 Participants n=4 Participants	664 Participants n=27 Participants
Race/Ethnicity, Customized White	1039 Participants n=93 Participants	539 Participants n=4 Participants	1578 Participants n=27 Participants
Race/Ethnicity, Customized Other	71 Participants n=93 Participants	32 Participants n=4 Participants	103 Participants n=27 Participants
Region of Enrollment United States	1597 Participants n=93 Participants	805 Participants n=4 Participants	2402 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects

Population: Per Protocol Set (PPS): All subjects in the FAS who received vaccine on Day 1, provided serology specimens which yielded valid serology assay results from both Day 1 and Day 29 (previously vaccinated subjects) or Day 1 and Day 57 (not previously vaccinated subjects) and for whom there was no protocol deviation that was medically assessed as having potential to impact the immunogenicity results. 1092 and 575 subjects in the QIVc and Comparator QIV groups had HAI assay data for this outcome.

The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.

Outcome measures

Outcome measures
Measure	QIVc n=1092 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=575 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses A/H1N1	78.0 Titer Interval 70.75 to 86.03	57.3 Titer Interval 50.76 to 64.63
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses B/Yamagata	35.6 Titer Interval 32.93 to 38.58	26.0 Titer Interval 23.54 to 28.63
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses B/Victoria	22.4 Titer Interval 20.7 to 24.19	19.6 Titer Interval 17.81 to 21.58

PRIMARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome)

The SCR is defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.

Outcome measures

Outcome measures
Measure	QIVc n=1092 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=575 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses A/H1N1	58.24 Percentage of participants Interval 55.25 to 61.19	46.78 Percentage of participants Interval 42.64 to 50.96
Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses B/Yamagata	46.52 Percentage of participants Interval 43.53 to 49.53	31.65 Percentage of participants Interval 27.87 to 35.63
Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses B/Victoria	30.31 Percentage of participants Interval 27.6 to 33.13	24.35 Percentage of participants Interval 20.89 to 28.07

PRIMARY outcome

Timeframe: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects

Population: PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome)

The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.

Outcome measures

Outcome measures
Measure	QIVc n=1078 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=572 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses	23.1 Titer Interval 21.21 to 25.12	23.9 Titer Interval 21.57 to 26.57

PRIMARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome)

The SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.

Outcome measures

Outcome measures
Measure	QIVc n=1078 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=572 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses	27.64 Percentage of participants Interval 24.99 to 30.42	30.77 Percentage of participants Interval 27.01 to 34.73

SECONDARY outcome

Timeframe: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects

Population: PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome)

The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.

Outcome measures

Outcome measures
Measure	QIVc n=1092 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=575 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses A/H1N1 Day 1 HAI GMT	14.0 Titer Interval 12.54 to 15.74	13.9 Titer Interval 12.11 to 16.04
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses A/H1N1 Day 29/57 HAI GMT	92.2 Titer Interval 83.62 to 101.71	82.9 Titer Interval 73.51 to 93.58
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses B/Yamagata Day 1 HAI GMT	6.7 Titer Interval 6.33 to 7.16	6.7 Titer Interval 6.23 to 7.26
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses B/Yamagata Day 29/57 HAI GMT	23.0 Titer Interval 21.21 to 24.89	24.7 Titer Interval 22.39 to 27.26
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses B/Victoria Day 1 HAI GMT	6.1 Titer Interval 5.77 to 6.38	6.0 Titer Interval 5.68 to 6.43
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses B/Victoria Day 29/57 HAI GMT	13.6 Titer Interval 12.58 to 14.61	14.8 Titer Interval 13.46 to 16.19

SECONDARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome)

The SCR is defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.

Outcome measures

Outcome measures
Measure	QIVc n=1092 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=575 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses A/H1N1 HAI SCR	58.52 Percentage of participants Interval 55.53 to 61.46	56.00 Percentage of participants Interval 51.83 to 60.1
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses B/Yamagata HAI SCR	38.64 Percentage of participants Interval 35.74 to 41.61	38.61 Percentage of participants Interval 34.61 to 42.73
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses B/Victoria HAI SCR	19.69 Percentage of participants Interval 17.37 to 22.17	20.87 Percentage of participants Interval 17.62 to 24.42

SECONDARY outcome

Timeframe: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects

Population: PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome)

The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.

Outcome measures

Outcome measures
Measure	QIVc n=1079 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=572 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses A/H3N2 Day 1 MN GMT	12.9 Titer Interval 11.87 to 13.96	12.6 Titer Interval 11.42 to 13.95
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses A/H3N2 Day 29/57 MN GMT	43.4 Titer Interval 39.58 to 47.52	44.7 Titer Interval 39.98 to 50.08

SECONDARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome)

The SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.

Outcome measures

Outcome measures
Measure	QIVc n=1079 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=572 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses	37.44 Percentage of participants Interval 34.55 to 40.41	39.34 Percentage of participants Interval 35.31 to 43.47

SECONDARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome)

GMR is defined as the geometric mean of the (within-subject) fold increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).

Outcome measures

Outcome measures
Measure	QIVc n=1092 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=575 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses A/H1N1 (cell) HAI GMR	5.34 Geometric mean ratio Interval 4.834 to 5.91	3.97 Geometric mean ratio Interval 3.506 to 4.493
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses B/Yamagata (cell) HAI GMR	4.12 Geometric mean ratio Interval 3.792 to 4.467	3.03 Geometric mean ratio Interval 2.735 to 3.348
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses B/Victoria (cell) HAI GMR	2.65 Geometric mean ratio Interval 2.45 to 2.864	2.31 Geometric mean ratio Interval 2.1 to 2.548
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses A/H1N1 (egg) HAI GMR	5.67 Geometric mean ratio Interval 5.117 to 6.29	5.11 Geometric mean ratio Interval 4.503 to 5.809
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses B/Yamagata (egg) HAI GMR	3.04 Geometric mean ratio Interval 2.808 to 3.298	3.27 Geometric mean ratio Interval 2.964 to 3.615
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses B/Victoria (egg) HAI GMR	2.14 Geometric mean ratio Interval 1.987 to 2.308	2.33 Geometric mean ratio Interval 2.126 to 2.558

SECONDARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: PPS (A randomly selected subset of subjects; 195 and 122 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) The MN assays for A/H1N1, B/Yamagata, and B/Victoria strains were only evaluated for cell-derived target viruses. Data were not collected for egg-derived target viruses.

GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).

Outcome measures

Outcome measures
Measure	QIVc n=195 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=122 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses A/H1N1 (cell) MN GMR	5.74 Geometric mean ratio Interval 4.356 to 7.573	4.29 Geometric mean ratio Interval 3.174 to 5.811
Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses B/Yamagata (cell) MN GMR	3.14 Geometric mean ratio Interval 2.561 to 3.854	2.86 Geometric mean ratio Interval 2.284 to 3.572
Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses B/Victoria (cell) MN GMR	1.88 Geometric mean ratio Interval 1.583 to 2.241	1.63 Geometric mean ratio Interval 1.344 to 1.966

SECONDARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for the outcome of GMR against the A/H3N2 vaccine strain by MN assay using cell-derived target viruses; 1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had data for the outcome of GMR against the A/H3N2 vaccine strain by MN assay using egg-derived target viruses)

GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).

Outcome measures

Outcome measures
Measure	QIVc n=1079 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=572 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses A/H3N2 (cell) MN GMR	2.11 Geometric mean ratio Interval 1.94 to 2.298	2.19 Geometric mean ratio Interval 1.977 to 2.436
Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses A/H3N2 (egg) MN GMR	3.13 Geometric mean ratio Interval 2.856 to 3.431	3.22 Geometric mean ratio Interval 2.878 to 3.608

SECONDARY outcome

Timeframe: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects)

Population: Solicited Safety Set, defined as all subjects in the FAS with any solicited AE data.

The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination.

Outcome measures

Outcome measures
Measure	QIVc n=1564 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=784 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) Solicited AEs	940 Participants	491 Participants
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) Solicited Local AEs	656 Participants	350 Participants
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) Solicited Systemic AEs	681 Participants	358 Participants
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) Analgesic/Antipyretic Use	240 Participants	136 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects

Population: Unsolicited Safety Set, defined as all subjects in the FAS with any unsolicited AE data.

The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29 for previously vaccinated subjects and from Day 1 to Day 57 for not previously vaccinated subjects. Related AEs = considered at least possibly related to study vaccination by the investigator; Severity = based on the greatest severity associated with a preferred term for a reported AE.

Outcome measures

Outcome measures
Measure	QIVc n=1597 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=805 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs Any AE	418 Participants	207 Participants
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs Any AE (Mild)	308 Participants	164 Participants
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs Any AE (Moderate)	98 Participants	41 Participants
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs Any AE (Severe)	12 Participants	2 Participants
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs Related AE	70 Participants	36 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects

Population: Unsolicited Safety Set

The percentage of subjects with any SAE, NOCD or AE leading to withdrawal during the study period from Day 1 to Day 181 for previously vaccinated subjects or from Day 1 to Day 209 for not previously vaccinated subjects. Definitions: SAEs = AEs defined as any untoward medical occurrence that at any dose resulted in one or more of the following: 1. Death, 2. Life-threatening 3. Required/prolonged hospitalization 4. Persistent or significant disability/incapacity 5. congenital anomaly/or birth defect 6. An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based on appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above

Outcome measures

Outcome measures
Measure	QIVc n=1597 Participants Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=805 Participants Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period SAE	15 Participants	7 Participants
Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period Related SAE	0 Participants	0 Participants
Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period AE leading to study withdrawal	3 Participants	0 Participants
Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period NOCD	22 Participants	13 Participants
Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period Death	2 Participants	0 Participants

Adverse Events

QIVc

Serious events: 15 serious events

Other events: 926 other events

Deaths: 2 deaths

Comparator QIV

Serious events: 7 serious events

Other events: 490 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	QIVc n=1597 participants at risk Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains	Comparator QIV n=805 participants at risk Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Infections and infestations Upper respiratory tract infection	3.7% 59/1597 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	5.5% 44/805 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders Injection site induration	17.3% 270/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	15.9% 125/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders Injection site erythema	25.8% 403/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	24.6% 193/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders Injection site ecchymosis	10.7% 168/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	10.8% 85/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders Injection site tenderness	27.9% 436/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	30.0% 235/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Metabolism and nutrition disorders Change of eating habits	17.4% 272/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	17.6% 138/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Nervous system disorders Sleepiness	26.9% 420/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	25.5% 200/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Gastrointestinal disorders Vomiting/throwing up	6.8% 106/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	6.2% 49/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Gastrointestinal disorders Diarrhea/loose stools	17.9% 280/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	16.3% 128/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
Psychiatric disorders Irritability	27.9% 436/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	29.6% 232/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
General disorders Fever (≥38.0°C)	6.8% 107/1564 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.	6.9% 54/784 • SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.

Additional Information

Seqirus Clinical Trial Manager

Seqirus

Phone: 1-855-358-8966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place