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Influenza, HumanPhase 3NCT03165617

Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age

A Phase 3 study testing QIVc and Non-influenza Comparator Vaccine in people with Influenza, Human, run by Seqirus at 40 sites in 8 countries.

Completed

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

Official record
Search all trials

Trial summary

This Phase 3/4, randomized, observer-blind, multi-center study, stratified study evaluated the immune (antibody) response, efficacy and safety of a cell-derived quadrivalent subunit influenza virus vaccine (Seqirus QIVc) in comparison with a non-influenza comparator, meningococcal serogroup A, C, W-135, and Y… Read more about this study

Who is it for?
Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
QIVc and Non-influenza Comparator Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,514 participants
Where
40 sitesin 8 countries
Study dates
25 May 2017to 30 Sep 2019
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 2 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female ≥2 to <18 years of age on the day of the first study vaccination
  • Subject's parent(s) or legal guardian(s) who was/were able to give informed consent/dissent after the nature of the study had been explained in accordance with the practices described in the study and according to local regulatory requirements
  • If the subject was of an age where, according to local regulations, informed assent was required, he/she must have provided assent to participate in the study
  • Subject/subject's parent(s) or legal guardian(s) was/were able to comply with study procedures and was/were available for follow-up; and
  • Subject was in generally good health as per the investigator's medical judgment

Who cannot join

  • Clinical signs of fever and/or an oral temperature of ≥100.4°F (38.0°C) within 3 days prior to vaccination;
  • A known history of any anaphylaxis, serious vaccine reactions or hypersensitivity to any of the vaccine components described in the Investigator's Brochure, or had any of the contraindications listed in the package insert of the comparator vaccine;
  • A history of Guillain-Barré syndrome or other de-myelinating diseases such as encephalomyelitis and transverse myelitis;
  • Female subject of childbearing potential (ie, post onset of menarche and before natural or induced menopause), sexually active, and who did not use any acceptable contraceptive methods for at least 2 months prior to study entry and who did not intend to use any acceptable contraceptive methods throughout subject participation (acceptable contraceptive methods included: abstinence; hormonal contraceptive [such as oral, injection, transdermal patch, implant]; diaphragm with spermicide; tubal occlusion device; intrauterine device [IUD]; tubal ligation; male partner using condom; or male partner having been vasectomized);
  • Pregnant or breast feeding female;
  • Subject and/or subject's parent/guardians who were not able to comprehend or follow all required study procedures for the entire period of the study;
Show all 16Show fewer
  • Received prior Meningococcal ACWY vaccination that conflicted with national recommendations or local practices for the timing of the primary or the booster vaccination;
  • Received influenza vaccination or had documented influenza disease in the last 6 months;
  • Known or suspected congenital or acquired immunodeficiency; or received immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or systemic corticosteroid therapy (prednisone or equivalent) at any dose for more than 2 consecutive weeks (14 days) within the past 3 months. Topical, inhaled and intra-nasal corticosteroids were permitted. Intermittent use (1 dose in 30 days) of intra-articular corticosteroids was also permitted;
  • Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or administration was planned during the study;
  • Participated in any clinical study with another investigational product within 30 days prior to first study visit or intended to participate in another clinical study at any time during the conduct of this study. Concomitant participation in an observational study (not involving drugs, vaccines, or medical devices) was acceptable;
  • Medical conditions or treatments contraindicating IM vaccination due to increased risk of bleeding. These included known bleeding disorders (such as thrombocytopenia), or treatment with anticoagulants (such as warfarin) in the 3 weeks preceding vaccination. Antiplatelet agents such as low-dose aspirin, ticlopidine (Ticlid) and clopidogrel (Plavix) were permitted;
  • Evidence or history (within the previous 12 months) of drug or alcohol abuse;
  • Study personnel or immediate family members (brother, sister, child, parent), the spouse of study personnel or individuals who were financially or emotionally dependent on study staff;
  • Participated in this study in a prior season, if applicable; or
  • Any clinical condition that, in the opinion of the investigator, may have interfered with the results of the study or pose additional risk to the subject due to participation in the study.

Trial locations and contacts

40 sites in 8 countries.

40 sites in 8 countries

Finland10 sites

  • 607 Espoo Vaccine Research Clinic

    Espoo

  • 603 Helsinki South Vaccine Research Clinic

    Helsinki

  • 604 Helsinki South Vaccine Research Clinic

    Helsinki

  • 600 Järvenpää Vaccine Research Clinic

    Jarvenpaa

  • 606 Kokkola Vaccine Research Clinic

    Kokkola, 67100

  • 605 Oulu Vaccine Research Clinic

    Oulu

  • 601 Pori Vaccine Research Clinic

    Pori

  • 602 Seinäjoki Vaccine Research Clinic

    Seinäjoki

  • 608 Tampere Vaccine Research Clinic

    Tampere

  • 609 Turku Vaccine Research Clinic

    Turku

Other trials in Finland

Philippines7 sites

  • 402 De La Salle Health Sciences Institute

    Dasmariñas, Cavite, 4114

  • 405 De La Salle Health Sciences Institute

    Dasmariñas, Cavite, 4114

  • 403 Philippine General Hospital

    Manila, National Capital Region, 1000

  • 404 Philippine General Hospital

    Manila, National Capital Region, 1000

  • 400 Research Institute For Tropical Medicine

    Muntinlupa, National Capital Region, 1781

  • 401 Research Institute For Tropical Medicine

    Muntinlupa, National Capital Region, 1781

  • 406 Research Institute For Tropical Medicine

    Muntinlupa, National Capital Region, 1781

Other trials in Philippines

Estonia6 sites

  • 503 Vee Family Doctors Centre

    Paide, Järvamaa, 72713

  • 500 Merelahe Family Doctors Centre

    Tallinn, Harju, 10617

  • 504 Merekivi Family Doctors Ltd

    Tallinn, Harju, 10617

  • 502 Medicum AS

    Tallinn, Harju, 13619

  • 505 Clinical Research Center

    Tartu, Tartu, 50106

  • 505 Clinical Research Center

    Tartu

Other trials in Estonia

Lithuania6 sites

  • 706 Private Office of Children Pulmonologist

    Alytus, Alytus Apskritis, 62142

  • 704 Kauno klinikine ligonine

    Kaunas, Kaunas County, 47116

  • 703 UAB InMedica

    Kaunas, Kaunas County, 48259

  • 702 JSC Saules seimos medicinos centras

    Kaunas, Kaunas County, 49449

  • 700 Kaunas Silainiai Outpatient Clinic

    Kaunas, Kauno Apskrits, 48259

  • 701 Naujininkai Outpatient Clinic

    Vilnius, Vilnaius Apskritis, 02169

Other trials in Lithuania

Poland6 sites

  • 805 Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • 804 Prywatny Gabinet Lekarski

    Dębica, Podkarpackie Voivodeship, 39-200

  • 800 Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) "Salmed" s. c.

    Łęczna, Lublin Voivodeship, 21-010

  • NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska

    Siemianowice Śląskie, Silesian Voivodeship, 41-103

  • 806 Specjalistyczny Szpital im. E. Szczeklika w Tarnowie

    Tarnów, Lesser Poland Voivodeship, 33-100

  • 803 Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

    Trzebnica, Lower Silesian Voivodeship, 55-100

Other trials in Poland

Australia2 sites

  • 300 Murdoch Childrens Research Institute

    Carlton, Victoria, 3010

  • 302 AusTrials Pty Ltd

    Sherwood, Queensland, 4075

Other trials in Australia

Thailand2 sites

  • 201 ChiangMai University

    Chiang Mai, 50200

  • 200 Srinagarind Hospital, Khon Kaen University

    Khon Kaen, Muang, 40002

Other trials in Thailand

Spain1 site

  • 900 Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

About this study

Official title: A Phase III/IV, Stratified, Randomized, Observer Blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Influenza Comparator Vaccine in Subjects ≥2 to <18 Years of Age

This Phase 3/4, randomized, observer-blind, multi-center study, stratified study evaluated the immune (antibody) response, efficacy and safety of a cell-derived quadrivalent subunit influenza virus vaccine (Seqirus QIVc) in comparison with a non-influenza comparator, meningococcal serogroup A, C, W-135, and Y (Menveo®, GlaxoSmithKline Biologicals, S.A.) in healthy pediatric subjects ≥2 Years to <18 Years of Age

Read the detailed description

This Phase 3/4, randomized, observer-blind, multi-center, stratified study evaluated the efficacy, safety, and immunogenicity of a cell-derived quadrivalent subunit influenza virus vaccine (Seqirus QIVc) compared to a non-influenza comparator vaccine in healthy male and female participants between 2 to <18 years of age. A total of 4514 children/teens were randomized, receiving either QIVc or the non-influenza comparator vaccine. The comparator was (meningococcal [Groups A, C, W-135, and Y] oligosaccharide diphtheria CRM197 conjugate vaccine [Men ACWY]). Randomized enrollment was stratified in a 1:1 ratio via an Interactive Response Technology (IRT) system which assigned the participants into two age cohorts: 2 to <9 years of age and 9 to <18 years of age. Subjects between 2 to <9 years of age were further stratified by previous influenza vaccine status ("previously vaccinated" or "not previously vaccinated").

Being tested
QIVc, Non-influenza Comparator Vaccine
Keywords
Influenza vaccine
Medical subject headings
Influenza, Human

What participants receive

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

  • QIVcBiological

    Also called Flucelvax Quadrivalent

    Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

  • Non-influenza Comparator VaccineBiological

    Non-influenza comparator vaccine for intramuscular use

Study groups in NCT03165617
Study groupRoleWhat they receive
QIVc (≥2 years to <18 Years of Age)ExperimentalCell-derived Seasonal Quadrivalent Influenza Vaccine
Receives: Biological: QIVc
Non-Influenza Comparator VaccineActive comparatorNon-Influenza Comparator Vaccine
Receives: Biological: Non-influenza Comparator Vaccine

What is being measured

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

  1. Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years

    The primary efficacy endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza (time-to-event analyses) due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season.

    Dataset Used: FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.

    The success criterion used for this primary objective was as follows: The efficacy of the QIVc was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE was above 20%.

    Measured: Day 14 to Day 180 or until the end of the influenza season, whichever is longer

  2. Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥3 to <18 Years

    The co-primary efficacy endpoint: was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza (time-to-event analyses) due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season.Absolute vaccine efficacy of QIVc by first occurrence RT-PCR or culture confirmed influenza, due to any influenza Type A and B strain in subjects ≥3 years to <18 years of age

    Measured: Day 14 to Day 180 or until the end of the influenza season, whichever is longer

Secondary outcomes (11)

  1. Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine

    The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years.

    Dataset used: FAS Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.

    Measured: Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

  2. Secondary Efficacy #2: First Occurrence of RT-PCR-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine

    The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of RT-PCR-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years

    Dataset used: FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.

    Measured: Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

  3. Secondary Efficacy #3: First Occurrence of Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine

    The secondary endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of culture-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years.

    Dataset used: FAS Efficacy

    Measured: Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

  4. Secondary Efficacy #4: First Occurrence of Culture-confirmed Influenza Due to Influenza Type A or B Strain Antigenically Matched to the Strains Selected for the Seasonal Vaccine

    The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of culture-confirmed influenza due to influenza Type A or B strain antigenically matched to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years.

    Measured: Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

  5. Secondary Immunogenicity: Geometric Mean Titers for 4 Influenza Strains (HI Assay)

    Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.

    Measured: Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects receiving 2 doses)

  6. ISecondary Immunogenicity: Percentage of Subjects Achieving Seroconversion for 4 Influenza Strains (HI Assay)

    Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.

    Seroconversion was defined as: either a prevaccination HI titer <1:10 and a postvaccination HI titer

    ≥1:40 or a prevaccination HI titer ≥1:10 and a ≥4 fold increase in postvaccination HI titer)

    Dataset used: FAS Immunogenicity = All subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination.

    Measured: Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects)

  7. Secondary Immunogenicity: Geometric Mean Ratio for 4 Influenza Strains (HI Assay)

    Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.

    Geometric mean ratios (GMRs) measure the ratio in immunogenicity titers within subject\

    Dataset used: FAS Immunogenicity = All subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination.

    Measured: Day 22/Day 1 (all previously vaccinated subjects) or Day 29/Day 1 and Day 50/Day 1 (all not previously vaccinated subjects receiving 2 doses)

  8. Secondary Immunogenicity: Percentage of Subjects With HI Titer ≥1:40 for All 4 Influenza Strains (HI Assay)

    Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.

    The measures for assessing immunogenicity as determined by HI were as follows: Percentage of subjects with an HI titer ≥1:40 on Day 22 (all "previously vaccinated" subjects receiving a single vaccine dose) or Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains

    Measured: Day 1 (all subjects), Day 22 (all "previously vaccinated" subjects receiving a single vaccine dose) or Days 29 and 50 (all "not previously vaccinated"subjects receiving 2 doses)

  9. Safety: Percentage of Subjects With Solicited Local and Systemic Adverse Events for 7 Days After Vaccination

    The measures for assessing safety and tolerability were as follows: Percentage of subjects with solicited local and systemic adverse events (AEs) for 7 days after vaccination on Day 1 (for "previously vaccinated" subjects) or for 7 days after vaccination on Day 1 and Day 29 (for "not previously vaccinated" subjects) in the QIVc group and the non-influenza comparator vaccine group.

    Dataset used: Solicited Safety Set

    Measured: days after vaccination on Day 1 (for "previously vaccinated" subjects) or for 7 days after vaccination on Day 1 and Day 29 (for "not previously vaccinated" subjects)

  10. Safety: Percentage of Subjects With Unsolicited AEs for 21 Days After Vaccination

    The measures for assessing safety and tolerability were as follows: Percentage of subjects with unsolicited AEs assessed from Day 1 to Day 22 (for "previously vaccinated" subjects) or from Day 1 to Day 50 (for "not previously vaccinated" subjects) in the QIVc group and the non-influenza comparator vaccine group.

    Dataset used: Unsolicited Safety Set (Unsolicited Adverse Events)

    Measured: Day 1 to Day 22 (for previously vaccinated subjects) or Day 1 to Day 50 (for not previously vaccinated subjects)

  11. Safety: Subjects With SAEs, AEs Leading to Withdrawal From Vaccination and/or the Study,(MAAEs) Within 30 Days of a 1st Occurrence, Post-ILI, and NOCDs Reported During Entire Study Participation or End of Flue Season, Whichever Was Longer

    The measures for assessing safety and tolerability were as follows: Percentage of subjects with SAEs, AEs leading to withdrawal from vaccination and/or the study, Medically-Attended AEs (MAAEs) within 30 days after the first occurrence of an ILI, and New Onset of Chronic Diseases (NOCDs) reported during the subject's entire participation in the study (ie, from Day 1 to Day 181 [for "previously vaccinated" subjects] or from Day 1 to Day 209 [for "not previously vaccinated" subjects]), or until the end of influenza season, whichever was longer, and all medications associated with these events.

    Dataset used: Overall Safety Set

    Measured: Day 1 to Day 181 (for previously vaccinated subjects) or 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.

  1. First posted24 May 2017
  2. Study start25 May 2017
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

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
Model description
Phase 3/4
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03165617
Sponsor's protocol ID
V130_12
Other IDs
2016-002883-15, 2016
Status last verified
Oct 2020
First submitted
17 May 2017
Last updated
22 Oct 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Seqirus supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\]).

Publications

  • Nolan T, Fortanier AC, Leav B, Poder A, Bravo LC, Szymanski HT, Heeringa M, Vermeulen W, Matassa V, Smolenov I, Edelman JM. Efficacy of a Cell-Culture-Derived Quadrivalent Influenza Vaccine in Children. N Engl J Med. 2021 Oct 14;385(16):1485-1495. doi: 10.1056/NEJMoa2024848.

    PubMed 34644472

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QIVc and Non-influenza Comparator Vaccine in people with Influenza, Human, run by Seqirus at 40 sites in 8 countries.

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 5 inclusion and 16 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Finland, Philippines, Estonia, Lithuania, Poland and 3 more countries. 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 22 Oct 2020). 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?

Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years (time frame: Day 14 to Day 180 or until the end of the influenza season, whichever is longer). The study lists 2 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 NCT03165617, 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 22 Oct 2020.

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