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CompletedNCT04074928Updated Jan 12, 2022Results posted

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

A Phase 3 interventional study of QIVc and Comparator QIV in Influenza, Human and Virus Diseases, sponsored by Seqirus. Completed at 47 sites in United States. Open to participants aged 6 Months to 47 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by Seqirus · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,414
Allocation
Randomized
Ages
6 Months to 47 Months
Sex
All
01

Study summary

This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

02

Conditions studied

  • Influenza
  • Human
  • Virus Diseases

Keywords

  • Influenza
  • RNA Virus
  • WHO Strains
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 2,414 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Seqirus is the lead sponsor of 52 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 47 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Individuals of 6 through 47 months of age on the day of informed consent.
  • Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  • Individuals who can comply with study procedures including follow-up
  • Individual is in generally good health as per the Investigator's medical judgement

Exclusion criteria

Exclusion Criteria:

  • Acute (severe) febrile illness
  • History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
  • A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
  • Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
  • Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
2,414 participants (actual)

Study arms

  • Experimental
    QIVc

    Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

    Biological: QIVc

  • Active comparator
    Comparator QIV

    Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

    Biological: Comparator QIV

Interventions

  • BiologicalQIVc

    Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.

    Also known as: Flucelvax Quadrivalent

  • BiologicalComparator QIV

    Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.

    Also known as: Afluria Quadrivalent

06

What researchers measure

Primary outcomes

  1. 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

    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.

    Time frame: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects

  2. 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

    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.

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

  3. Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses

    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.

    Time frame: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects

  4. Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses

    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.

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

Secondary outcomes

  1. 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

    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.

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

  2. 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

    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.

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

  3. Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses

    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.

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

  4. Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses

    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.

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

  5. 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

    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).

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

  6. 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

    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).

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

  7. Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and 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).

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

  8. Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)

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

    Time frame: 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)

  9. Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs

    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.

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

  10. 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

    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

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

07

Results

Posted Jan 12, 2022

Participant flow

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

Participant flow — Overall Study
MilestoneQIVcComparator QIV
Started1605809
Received study vaccine1597805
Completed1370710
Not completed23599

Outcome measures

PrimaryImmunogenicity 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

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.

Time frame:
Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Titer
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
TiterQIVcComparator QIV
A/H1N178.0 (70.75 to 86.03)57.3 (50.76 to 64.63)
B/Yamagata35.6 (32.93 to 38.58)26.0 (23.54 to 28.63)
B/Victoria22.4 (20.70 to 24.19)19.6 (17.81 to 21.58)
Statistical analysis
  • QIVc vs Comparator QIV · Gmt ratio: 0.73 · 95% CI 0.645 to 0.836
  • QIVc vs Comparator QIV · Gmt ratio: 0.73 · 95% CI 0.656 to 0.809
  • QIVc vs Comparator QIV · Gmt ratio: 0.88 · 95% CI 0.791 to 0.972
PrimaryImmunogenicity 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

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.

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
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
Percentage of participantsQIVcComparator QIV
A/H1N158.24 (55.25 to 61.19)46.78 (42.64 to 50.96)
B/Yamagata46.52 (43.53 to 49.53)31.65 (27.87 to 35.63)
B/Victoria30.31 (27.60 to 33.13)24.35 (20.89 to 28.07)
Statistical analysis
  • QIVc vs Comparator QIV · Scr difference: -11.46 · 95% CI -16.447 to -6.423
  • QIVc vs Comparator QIV · Scr difference: -14.87 · 95% CI -19.610 to -9.983
  • QIVc vs Comparator QIV · Scr difference: -5.96 · 95% CI -10.327 to -1.440
PrimaryImmunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses

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.

Time frame:
Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Titer
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses
TiterQIVcComparator QIV
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses23.1 (21.21 to 25.12)23.9 (21.57 to 26.57)
Statistical analysis
  • QIVc vs Comparator QIV · Gmt ratio: 1.04 · 95% CI 0.927 to 1.160
PrimaryImmunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses

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.

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses
Percentage of participantsQIVcComparator QIV
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses27.64 (24.99 to 30.42)30.77 (27.01 to 34.73)
Statistical analysis
  • QIVc vs Comparator QIV · Scr difference: 3.13 · 95% CI -1.443 to 7.812
SecondaryImmunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses

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.

Time frame:
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Titer
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
TiterQIVcComparator QIV
A/H1N1 Day 1 HAI GMT14.0 (12.54 to 15.74)13.9 (12.11 to 16.04)
A/H1N1 Day 29/57 HAI GMT92.2 (83.62 to 101.71)82.9 (73.51 to 93.58)
B/Yamagata Day 1 HAI GMT6.7 (6.33 to 7.16)6.7 (6.23 to 7.26)
B/Yamagata Day 29/57 HAI GMT23.0 (21.21 to 24.89)24.7 (22.39 to 27.26)
B/Victoria Day 1 HAI GMT6.1 (5.77 to 6.38)6.0 (5.68 to 6.43)
B/Victoria Day 29/57 HAI GMT13.6 (12.58 to 14.61)14.8 (13.46 to 16.19)
Statistical analysis
  • QIVc vs Comparator QIV · Gmt ratio: 0.90 · 95% CI 0.790 to 1.024
  • QIVc vs Comparator QIV · Gmt ratio: 1.08 · 95% CI 0.968 to 1.195
  • QIVc vs Comparator QIV · Gmt ratio: 1.09 · 95% CI 0.986 to 1.202
SecondaryImmunogenicity 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

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.

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
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
Percentage of participantsQIVcComparator QIV
A/H1N1 HAI SCR58.52 (55.53 to 61.46)56.00 (51.83 to 60.10)
B/Yamagata HAI SCR38.64 (35.74 to 41.61)38.61 (34.61 to 42.73)
B/Victoria HAI SCR19.69 (17.37 to 22.17)20.87 (17.62 to 24.42)
Statistical analysis
  • QIVc vs Comparator QIV · Scr difference: -2.52 · 95% CI -7.526 to 2.461
  • QIVc vs Comparator QIV · Scr difference: -0.04 · 95% CI -4.912 to 4.911
  • QIVc vs Comparator QIV · Scr difference: 1.18 · 95% CI -2.805 to 5.353
SecondaryImmunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses

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.

Time frame:
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Titer
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
TiterQIVcComparator QIV
A/H3N2 Day 1 MN GMT12.9 (11.87 to 13.96)12.6 (11.42 to 13.95)
A/H3N2 Day 29/57 MN GMT43.4 (39.58 to 47.52)44.7 (39.98 to 50.08)
Statistical analysis
  • QIVc vs Comparator QIV · Gmt ratio: 1.03 · 95% CI 0.914 to 1.165
SecondaryImmunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses

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.

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
Percentage of participantsQIVcComparator QIV
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses37.44 (34.55 to 40.41)39.34 (35.31 to 43.47)
Statistical analysis
  • QIVc vs Comparator QIV · Scr difference: 1.89 · 95% CI -3.006 to 6.856
SecondaryImmunogenicity 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

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).

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Geometric mean ratio
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
Geometric mean ratioQIVcComparator QIV
A/H1N1 (cell) HAI GMR5.34 (4.834 to 5.910)3.97 (3.506 to 4.493)
B/Yamagata (cell) HAI GMR4.12 (3.792 to 4.467)3.03 (2.735 to 3.348)
B/Victoria (cell) HAI GMR2.65 (2.450 to 2.864)2.31 (2.100 to 2.548)
A/H1N1 (egg) HAI GMR5.67 (5.117 to 6.290)5.11 (4.503 to 5.809)
B/Yamagata (egg) HAI GMR3.04 (2.808 to 3.298)3.27 (2.964 to 3.615)
B/Victoria (egg) HAI GMR2.14 (1.987 to 2.308)2.33 (2.126 to 2.558)
SecondaryImmunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and 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).

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Geometric mean ratio
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
Geometric mean ratioQIVcComparator QIV
A/H1N1 (cell) MN GMR5.74 (4.356 to 7.573)4.29 (3.174 to 5.811)
B/Yamagata (cell) MN GMR3.14 (2.561 to 3.854)2.86 (2.284 to 3.572)
B/Victoria (cell) MN GMR1.88 (1.583 to 2.241)1.63 (1.344 to 1.966)
SecondaryImmunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and 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).

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Geometric mean ratio
Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses
Geometric mean ratioQIVcComparator QIV
A/H3N2 (cell) MN GMR2.11 (1.940 to 2.298)2.19 (1.977 to 2.436)
A/H3N2 (egg) MN GMR3.13 (2.856 to 3.431)3.22 (2.878 to 3.608)
SecondarySafety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)

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

Time frame:
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)
Reported as:
Count of participants · Participants
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)
ParticipantsQIVcComparator QIV
Solicited AEs940491
Solicited Local AEs656350
Solicited Systemic AEs681358
Analgesic/Antipyretic Use240136
SecondarySafety Endpoint: Percentage of Subjects With Any Unsolicited AEs

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.

Time frame:
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Count of participants · Participants
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs
ParticipantsQIVcComparator QIV
Any AE418207
Any AE (Mild)308164
Any AE (Moderate)9841
Any AE (Severe)122
Related AE7036
SecondarySafety 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

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

Time frame:
Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects
Reported as:
Count of participants · 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
ParticipantsQIVcComparator QIV
SAE157
Related SAE00
AE leading to study withdrawal30
NOCD2213
Death20

Adverse events

Collected over 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). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
QIVc2/1,597 (0.1%)15/1,597 (0.9%)926/1,597 (58%)
Comparator QIV0/805 (0%)7/805 (0.9%)490/805 (60.9%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventQIVcComparator QIV
BronchiolitisInfections and infestations1/15973/805
PneumoniaInfections and infestations3/15970/805
AsthmaRespiratory, thoracic and mediastinal disorders2/15971/805
SeizureNervous system disorders2/15970/805
Unresponsive to stimuliNervous system disorders0/15971/805
ConstipationGastrointestinal disorders0/15971/805
DehydrationMetabolism and nutrition disorders1/15971/805
Rhinovirus infectionInfections and infestations1/15971/805
Metapneumovirus infectionInfections and infestations0/15971/805
Road traffic accidentInjury, poisoning and procedural complications1/15970/805
Most frequent other events
Showing 10 of 11
Most frequent other events
EventQIVcComparator QIV
Injection site tendernessGeneral disorders436/1564235/784
IrritabilityPsychiatric disorders436/1564232/784
SleepinessNervous system disorders420/1564200/784
Injection site erythemaGeneral disorders403/1564193/784
Diarrhea/loose stoolsGastrointestinal disorders280/1564128/784
Change of eating habitsMetabolism and nutrition disorders272/1564138/784
Injection site indurationGeneral disorders270/1564125/784
Injection site ecchymosisGeneral disorders168/156485/784
Fever (≥38.0°C)General disorders107/156454/784
Vomiting/throwing upGastrointestinal disorders106/156449/784

Baseline characteristics

Full Analysis Set (FAS), defined as all enrolled subjects who were randomized and received a study vaccination.

Age, Categorical
Age, Categorical(Participants)QIVcComparator QIVTotal
<=18 years15978052402
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(months)QIVcComparator QIVTotal
Mean28.1 ± 11.5428.2 ± 11.6328.1 ± 11.57
Sex: Female, Male
Sex: Female, Male(Participants)QIVcComparator QIVTotal
Female7943991193
Male8034061209
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)QIVcComparator QIVTotal
Hispanic or Latino434226660
Not Hispanic or Latino11605751735
Unknown or Not Reported347
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)QIVcComparator QIVTotal
American Indian or Alaska Native111122
Asian13821
Native Hawaiian or Other Pacific Islander8614
Black or African American455209664
White10395391578
Other7132103
Region of Enrollment
Region of Enrollment(Participants)QIVcComparator QIVTotal
United States15978052402
08

Study locations

47 sites
  • 84035 CCR Research
    Mobile, Alabama 36608, United States
  • 84040 Southland Clnical Research Center
    Anaheim, California 92804, United States
  • 84044 Premier Health Research Center
    Downey, California 90240, United States
  • 84028 Orange County Research Institute
    Ontario, California 91763, United States
  • 84029 Center for Clinical Trials
    Paramount, California 90723, United States
  • 84012 Benchmark Research
    Sacramento, California 95864, United States
  • 84006 California Research Foundation
    San Diego, California 92123-1881, United States
  • 84001 Acevedo Clincal Research Associates
    Miami, Florida 33142, United States
  • 84005 Sunshine Research Center
    Opa-locka, Florida 33054, United States
  • 84052 Tekton Research
    Chamblee, Georgia 30341, United States
  • 84036 Advanced Clinical Research
    Meridian, Idaho 83642, United States
  • 84027 Heartland Research Associates
    El Dorado, Kansas 67042, United States
  • 84020 Heartland Research Associates
    Newton, Kansas 67114, United States
  • 84014 Heartland Research Associates
    Wichita, Kansas 67205, United States
  • 84026 Heartland Research Associates
    Wichita, Kansas 67207, United States
  • 84041 Kentucky Pediatric/ Adult Research
    Bardstown, Kentucky 40004, United States
  • 84009 Bluegrass Clinical Research Inc.
    Louisville, Kentucky 40291, United States
  • 84008 Meridian Clinical Research
    Baton Rouge, Louisiana 70806, United States
  • 84046 ACC Pediatric Research
    Haughton, Louisiana 71037, United States
  • 84004 Benchmark Research
    Metairie, Louisiana 70006, United States
  • 84022 Med Pharmics
    Metairie, Louisiana 70006, United States
  • 84053 MedPharmics
    Gulfport, Mississippi 39503, United States
  • 84051 Office of Craig A. Spiegel
    Bridgeton, Missouri 63044, United States
  • 84016 Center for Pharmaceutical Research
    Kansas City, Missouri 64114, United States
  • 84037 Meridian Clinical Research
    Norfolk, Nebraska 68701, United States
  • 84017 Meridian Clinical Research
    Omaha, Nebraska 68116, United States
  • 84033 Med Pharmics
    Albuquerque, New Mexico 87102, United States
  • 84013 Regional Clinical Research
    Binghamton, New York 13901, United States
  • 84045 Dayton Clinical
    Dayton, Ohio 45406, United States
  • 84003 PriMed Clinical Research
    Dayton, Ohio 45419, United States
  • 84015 Meridian Clinical Research
    Dakota Dunes, South Dakota 57049, United States
  • 84032 Clinical Research Associates
    Nashville, Tennessee 37203, United States
  • 84007 Benchmark Research
    Austin, Texas 78705, United States
  • 84023 Ventavia Research Group
    Fort Worth, Texas 76104, United States
  • 84042 Universtiy of North Texas Health Science Center
    Fort Worth, Texas 76107, United States
  • 84043 Benchmark Research
    Fort Worth, Texas 76135, United States
  • 84047 Ventavia Research Group
    Houston, Texas 77008, United States
  • 84011 West Houston Clinical Research
    Houston, Texas 77055, United States
  • 84019 Ventavia Research Group
    Keller, Texas 76248, United States
  • 84021 Benchmark Research
    San Angelo, Texas 76904, United States
  • 84002 Tekton Research
    San Antonio, Texas 78240, United States
  • 84025 Pediatric Healthcare of NW Houston
    Tomball, Texas 77375, United States
  • 84018 Tanner Clinic
    Layton, Utah 84041, United States
  • 84050 JBR Clinical Research Group
    Salt Lake City, Utah 84107, United States
  • 84048 J. Lewis Research/Foothill Family Clinic South
    Salt Lake City, Utah 84121, United States
  • 84031 Advanced Clinical Research
    West Jordan, Utah 84088, United States
  • 84039 Pediatric Research of Charlottesville
    Charlottesville, Virginia 22902, United States
09

References and documents

Publications

  • Essink BJ, Heeringa M, Jeanfreau RJ, Finn D, Matassa V, Edelman J, Hohenboken M, Molrine D. Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial. Pediatrics. 2022 Nov 1;150(5):e2022057509. doi: 10.1542/peds.2022-057509. PubMed 36214072 ↗

Study documents

  • Study protocol · Dec 9, 2019
  • Statistical analysis plan · May 13, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04074928
Lead sponsor
Seqirus
Responsible party
Sponsor
First posted
Aug 30, 2019
Start date
Sep 6, 2019
Primary completion
Sep 3, 2020
Completion
Sep 3, 2020
Results posted
Jan 12, 2022
Last update
Jan 12, 2022

Study contacts

Clinical Program Director
study director · Seqirus

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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