Trial · NCT04074928
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
NCT04074928, Phase 3, Completed, Seqirus; results first posted 2022-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects. Trials, record NCT04074928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04074928
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
- NCT number
- NCT04074928
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,414 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human, Virus Diseases
- Interventions
- QIVc, Comparator QIV
- First posted
- 2019-08-30
- Last updated
- 2022-01-12
- Other registries' IDs
- eudract:2020-002785-13
- Results first posted
- 2022-01-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects | 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. |
| Primary | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | 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. |
| Primary | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects | 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. |
| Primary | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | 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. |
| Secondary | 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 | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects | 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. |
| Secondary | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | 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. |
| Secondary | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects | 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. |
| Secondary | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | 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. |
| Secondary | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | 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). |
| Secondary | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | 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). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects | 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. | Titer | GEOMETRIC_MEAN |
| PRIMARY | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Percentage of participants | NUMBER |
| PRIMARY | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects | PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Titer | GEOMETRIC_MEAN |
| PRIMARY | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Percentage of participants | NUMBER |
| SECONDARY | 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 | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Titer | GEOMETRIC_MEAN |
| SECONDARY | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Percentage of participants | NUMBER |
| SECONDARY | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects | PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Percentage of participants | NUMBER |
| SECONDARY | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Geometric mean ratio | NUMBER |
| SECONDARY | 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 | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects | 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. | Geometric mean ratio | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | QIVc | A/H1N1 | 78.0 | 95% Confidence Interval 70.75 to 86.03 | 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 | Comparator QIV | A/H1N1 | 57.3 | 95% Confidence Interval 50.76 to 64.63 | 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 | QIVc | B/Yamagata | 35.6 | 95% Confidence Interval 32.93 to 38.58 | 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 | Comparator QIV | B/Yamagata | 26.0 | 95% Confidence Interval 23.54 to 28.63 | 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 | QIVc | B/Victoria | 22.4 | 95% Confidence Interval 20.70 to 24.19 | 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 | Comparator QIV | B/Victoria | 19.6 | 95% Confidence Interval 17.81 to 21.58 | Titer |
| 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 | QIVc | A/H1N1 | 58.24 | 95% Confidence Interval 55.25 to 61.19 | 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 | Comparator QIV | A/H1N1 | 46.78 | 95% Confidence Interval 42.64 to 50.96 | 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 | QIVc | B/Yamagata | 46.52 | 95% Confidence Interval 43.53 to 49.53 | 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 | Comparator QIV | B/Yamagata | 31.65 | 95% Confidence Interval 27.87 to 35.63 | Percentage of participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QIVc | 1,605 | |
| Overall Study | STARTED | Comparator QIV | 809 | |
| Overall Study | Received Study Vaccine | QIVc | 1,597 | |
| Overall Study | Received Study Vaccine | Comparator QIV | 805 | |
| Overall Study | COMPLETED | QIVc | 1,370 | |
| Overall Study | COMPLETED | Comparator QIV | 710 | |
| Overall Study | NOT COMPLETED | QIVc | 235 | |
| Overall Study | NOT COMPLETED | Comparator QIV | 99 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | QIVc | 59 | 1,597 | |
| other | Upper respiratory tract infection | Infections and infestations | Comparator QIV | 44 | 805 | |
| other | Injection site induration | General disorders | QIVc | 270 | 1,564 | |
| other | Injection site induration | General disorders | Comparator QIV | 125 | 784 | |
| other | Injection site erythema | General disorders | QIVc | 403 | 1,564 | |
| other | Injection site erythema | General disorders | Comparator QIV | 193 | 784 | |
| other | Injection site ecchymosis | General disorders | QIVc | 168 | 1,564 | |
| other | Injection site ecchymosis | General disorders | Comparator QIV | 85 | 784 | |
| other | Injection site tenderness | General disorders | QIVc | 436 | 1,564 | |
| other | Injection site tenderness | General disorders | Comparator QIV | 235 | 784 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QIVc | 2 | 1,597 |
| Total, all-cause mortality | Comparator QIV | 0 | 805 |
| Total, other adverse events | QIVc | 926 | 1,597 |
| Total, other adverse events | Comparator QIV | 490 | 805 |
| Total, serious adverse events | QIVc | 15 | 1,597 |
| Total, serious adverse events | Comparator QIV | 7 | 805 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36214072 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| QIVc vs Comparator QIV: deaths from any cause | Trial comparisons |
| QIVc vs Comparator QIV: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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