Influenza, HumanPhase 3NCT03932682
Efficacy Study With QIVc in Pediatric Subjects
A Phase 3 study testing QIVc and Comparator in people with Influenza, Human, run by Seqirus at 74 sites in 15 countries.
Trial summary
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47… Read more about this study
- Who is it for?
- Ages 6 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- QIVc and Comparator
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,723 participants
- Where
- 74 sitesin 15 countries
- Study dates
- 13 May 2019to 13 Feb 2024
- Phase
- Phase 3
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
- In order to participate in this study, all subjects must meet all of the inclusion criteria described.
- 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.
- Individuals in generally good health as per the Investigator's medical judgement.
- If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.
Who cannot join
- Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
- 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.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
- A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
- Abnormal function of the immune system resulting from a clinical condition
- Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
- Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.
- Additional eligibility criteria are provided in the study protocol.
Trial locations and contacts
74 sites in 15 countries.
74 sites in 15 countries
Philippines12 sites
60817-Health Index Multispecialty Clinic
Bacoor
60801-Chong Hua Hospital
Cebu City
60812-De La Salle Medical and Health Sciences Institute
Dasmariñas
60816-De La Salle Medical and Health Sciences Institute
Dasmariñas
60808-University of the Philippines Manila Development Foundation Inc
Ermita, Manila, 1000
60806-Mary Chiles General Hospital
Manila, 1008
60814-Philippine General Hospital
Manila
60815-Philippine General Hospital
Manila
60818-Philippine General Hospital
Manila
60810-UERM Memorial Medical Center
Quezon City, Quezon
60811-UERM Memorial Medical Center
Quezon City
60813-Philippine Children's Medical Center
Quezon City
South Africa9 sites
71006-Madibeng Centre for Research
Brits
71004-Tread Research
Cape Town
71007-Allergy & Immunology Unit
Cape Town
71002-Synergy Biomed Research Institute
East London
71009-Perinatal HIV Research Unit, Tshepong Hospital
Klerksdorp
71001-Be Part Yoluntu Centre
Paarl
71008-Clinical Trial Systems
Pretoria
71003-Soweto Clinical Trials Centre
Soweto
71005-Limpopo Clinical Research Initiative
Thabazimbi
Poland8 sites
61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.
Bydgoszcz, 85-090
61603-Jerzy Brzostek Prywatny Gabinet Lekarski
Dębica, 39-200
61607-Gdanskie Centrum Zdrowia Sp. z o.o.
Gdansk, 80-542
61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska
Krakow, 31-302
61608-Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302
61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice
Siemianowice Śląskie, 41-103
61601-ETG Network- Skierniewice,Clinmed Research
Skierniewice, 96-100
61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy
Trzebnica, 55-100
Bulgaria7 sites
10008-Medical Center Viva Feniks
Dobrich
10007-MHAT Dr. Stamen Iliev AD
Montana
10003-UMHAT Dr. Georgi Stranski EAD
Pleven
10002-UMHAT Sveti Georgi EAD
Plovdiv
10006-UMHAT-Plovdiv AD
Plovdiv
10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD
Rousse
10009-Medical Center Unimed Eood
Sevlievo
Estonia6 sites
23305-Vee Family Doctor's Centre
Paide, 72713
23301-Innomedica OÜ
Tallinn, 10117
23303-Al Mare Perearstikeskus OU
Tallinn, 10617
23304-Merelahe Family Doctors Center
Tallinn, 10617
23307-Tallinn Children's Hospital
Tallinn
23302-Clinical Research Centre
Tartu, 10117
Czechia5 sites
20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost
Chlumec nad Cidlinou, 503 51
20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost
Jindřichův Hradec, 377 01
20302-MUDr. Daniela Pniakova s.r.o.
Ostrava, 700 30
20304-MUDr. David Zeman s.r.o.
Ostrava-poruba, 708 00
20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost
Pardubice, 530 09
Malaysia5 sites
45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah
Kangar, Perlis, 01000
45801-University Malaya Medical Centre
Kuala Lumpur, 59100
45803-Sarawak General Hospital
Kuching, Sarawak, 93586
45805-Klinik Kesihatan Putrajaya Presint 9
Putrajaya, Wilyah Persekutuan Putrajaya, 62250
45802-Hospital Sibu
Sibu, Sarawak, 96000
Pakistan5 sites
58602-Shifa International Hospital
Islamabad
58604-The Aga Khan
Karachi
58605-Avicenna Hospital
Lahore
58607-Central Park Teaching Hospital
Lahore
58601-Al Shifa Research Centre
Rawalpindi
Romania4 sites
64201-SC Sana Monitoring SRL.
Bucharest, 011025
64205-Sc Med Fam Apolo srl
Calarasi, 910160
64202-Spitalul Municipal Caracal
Caracal, 235200
64206-S.C Centrul Clinic Mediquest S.R.L
Sângeorgiu de Mureş, 547530
Honduras3 sites
34001-Demedica
San Pedro Sula, 21104
34003-Clínica Médica y Dental CLIMEDENTY
Tegucigalpa, 11101
34002-Inversiones en Investigación Médica (INVERIME)
Tegucigalpa, 2449
Thailand3 sites
76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
76405-Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400
Ukraine3 sites
80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU
Chernivtsi, 58023
80405-CI Dnipro Children's City CH #5 of Dnipro City Council
Dnipro, 49027
80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU
Vinnytsia, 21000
New Zealand2 sites
55403-Christchurch Clinical Studies Trust
Christchurch, 8011
55401-Wellington Hospital
Wellington, 6021
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
- Conditions
- Influenza, Human
- Being tested
- QIVc, Comparator
- 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
QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
ComparatorBiological
Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
| Study group | Role | What they receive |
|---|---|---|
| QIVc | Experimental | Cell-derived Quadrivalent Influenza Vaccine Receives: Biological: QIVc |
| Comparator | Active comparator | Non-influenza Comparator Receives: Biological: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match
First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Measured: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine
First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Measured: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Secondary outcomes (13)
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine
First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Measured: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Measured: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season
Measured: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
HI = hemagglutination inhibition
Adjusted GMTs are presented
Measured: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
SCR is defined as the percentage of subjects with 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
Measured: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer
Adjusted GMRs are presented
Measured: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
Measured: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
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
Measured: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer
Measured: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group
Measured: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination
Measured: 28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group
Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237).
Measured: Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects
Safety Endpoint: Percentage of Subjects With Medically-attended AEs
Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group
Measured: If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start13 May 2019
- Primary completion30 Nov 2023
- Study completion13 Feb 2024
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 Influenza, HumanStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,723 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Program Director, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932682
- Sponsor's protocol ID
- V130_14
- Other IDs
- 2018-001857-29, 2018
- Status last verified
- Feb 2025
- First submitted
- 22 Apr 2019
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Seqirus will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact Seqirus at seqirus.clinicaltrials@seqirus.com.
Publications
Poder A, Ong-Lim AL, Rivera Medina DM, Zaman K, Makedonska I, de Bruijn M, Matassa V, Fortanier AC, Heijnen E, Hohenboken M, Molrine DC. Efficacy, immunogenicity, and safety of a cell culture-derived quadrivalent influenza vaccine compared with a non-influenza vaccine in infants and children across five influenza seasons: a phase 3, multinational, observer-blind, randomised controlled trial. Lancet Child Adolesc Health. 2026 May;10(5):352-363. doi: 10.1016/S2352-4642(26)00009-X.
PubMed 41962984