InfluenzaPhase 3NCT04074928

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

A Phase 3 study testing QIVc and Comparator QIV in people with Influenza and Human, run by Seqirus at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 47 monthsHealthy volunteers can take part
Conditions the study is for: Influenza, Human, Virus Diseases
What is being tested?: QIVc and Comparator QIV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,414 participants
Where: 47 sitesUnited States
Study dates: 6 Sep 2019to 3 Sep 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 47 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

United States47 sites

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

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About this study

Official title: A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months

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.

Conditions: Influenza, Human, Virus Diseases
Being tested: QIVc, Comparator QIV
Keywords: Influenza, RNA Virus, WHO Strains
Medical subject headings: Influenza, Human, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QIVcBiological
Also called Flucelvax Quadrivalent
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.
Comparator QIVBiological
Also called Afluria Quadrivalent
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.

Study groups in NCT04074928
Study group	Role	What they receive
QIVc	Experimental	Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains Receives: Biological: QIVc
Comparator QIV	Active comparator	Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains Receives: Biological: Comparator QIV

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

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.
Measured: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
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.
Measured: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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.
Measured: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
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.
Measured: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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).
Measured: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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).
Measured: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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).
Measured: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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.
Measured: 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)
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.
Measured: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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
Measured: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 20193 Sep 2020

First posted30 Aug 2019
Study start6 Sep 2019
Primary completion3 Sep 2020
Study completion3 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 2,414 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04074928
Sponsor's protocol ID: V130_10
Other IDs: 2020-002785-13
Status last verified: Dec 2021
First submitted: 27 Aug 2019
Last updated: 12 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months
ClinicalTrials.gov ID: NCT04074928
Acronym / sponsor ID: V130_10
Conditions: Influenza, Human, Virus Diseases
Keywords: Influenza, RNA Virus, WHO Strains
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,414 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 6 Sep 2019 (actual)
Primary completion: 3 Sep 2020 (actual)
Study completion: 3 Sep 2020 (actual)
First posted: 30 Aug 2019 (actual)
Results: Posted 12 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QIVc	Experimental	Biological: QIVcCell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV	Active comparator	Biological: Comparator QIVComparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Who may qualify

Ages: 6 to 47 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QIVcAlso: Flucelvax QuadrivalentPreviously 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.	Biological	QIVc
Comparator QIVAlso: Afluria QuadrivalentPreviously 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.	Biological	Comparator QIV

Primary outcome

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

10 secondary outcomes

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
Time frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
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
Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
Time frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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
Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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
Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses
Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)
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)
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs
Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
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
Time frame: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects

Results and safety

Results posted to the registry on 12 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QIVc	1,605	1,370
Comparator QIV	809	710

Primary outcome: 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

Time frame: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	QIVc n = 1092	Comparator QIV n = 575
A/H1N1	78.0 (70.75 to 86.03)	57.3 (50.76 to 64.63)
B/Yamagata	35.6 (32.93 to 38.58)	26.0 (23.54 to 28.63)
B/Victoria	22.4 (20.70 to 24.19)	19.6 (17.81 to 21.58)

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)

Population analysed: 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.

Primary outcome: 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

Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	QIVc n = 1092	Comparator QIV n = 575
A/H1N1	58.24 (55.25 to 61.19)	46.78 (42.64 to 50.96)
B/Yamagata	46.52 (43.53 to 49.53)	31.65 (27.87 to 35.63)
B/Victoria	30.31 (27.60 to 33.13)	24.35 (20.89 to 28.07)

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)

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

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

Time frame: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	QIVc n = 1078	Comparator QIV n = 572
Value	23.1 (21.21 to 25.12)	23.9 (21.57 to 26.57)

QIVc vs Comparator QIV: GMT ratio: 1.04 (95% CI 0.927 to 1.160)

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

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

Time frame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	QIVc n = 1078	Comparator QIV n = 572
Value	27.64 (24.99 to 30.42)	30.77 (27.01 to 34.73)

QIVc vs Comparator QIV: SCR difference: 3.13 (95% CI -1.443 to 7.812)

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

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QIVc	15 of 1,597 (0.9%)	926 of 1,597 (58%)	2 of 1,597
Comparator QIV	7 of 805 (0.9%)	490 of 805 (60.9%)	0 of 805

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36214072Essink 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Program Director study director

Seqirus

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QIVc and Comparator QIV in people with Influenza and Human, run by Seqirus at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.