Efficacy Study With QIVc in Pediatric Subjects

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: QIVc; Biological: Comparator

• Study Type: Interventional
• Enrollment (Actual): 5723
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • International Centre for Diarrhoeal Disease Research, Bangladesh
• Bulgaria
  • Dobrich, Bulgaria
    • 10008-Medical Center Viva Feniks
  • Montana, Bulgaria
    • 10007-MHAT Dr. Stamen Iliev AD
  • Pleven, Bulgaria
    • 10003-UMHAT Dr. Georgi Stranski EAD
  • Plovdiv, Bulgaria
    • 10002-UMHAT Sveti Georgi EAD
  • Plovdiv, Bulgaria
    • 10006-UMHAT-Plovdiv AD
  • Ruse, Bulgaria
    • 10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD
  • Sevlievo, Bulgaria
    • 10009-Medical Center Unimed Eood
• Czechia
  • Chlumec Nad Cidlinou, Czechia, 503 51
    • 20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost
  • Jindřichův Hradec, Czechia, 377 01
    • 20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost
  • Ostrava, Czechia, 700 30
    • 20302-MUDr. Daniela Pniakova s.r.o.
  • Ostrava-poruba, Czechia, 708 00
    • 20304-MUDr. David Zeman s.r.o.
  • Pardubice, Czechia, 530 09
    • 20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost
• Estonia
  • Paide, Estonia, 72713
    • 23305-Vee Family Doctor's Centre
  • Tallin, Estonia, 10617
    • 23303-Al Mare Perearstikeskus OU
  • Tallinn, Estonia, 10117
    • 23301-Innomedica OÜ
  • Tallinn, Estonia, 10617
    • 23304-Merelahe Family Doctors Center
  • Tallinn, Estonia
    • 23307-Tallinn Children's Hospital
  • Tartu, Estonia, 10117
    • 23302-Clinical Research Centre
• Honduras
  • San Pedro Sula, Honduras, 21104
    • 34001-Demedica
  • Tegucigalpa, Honduras, 11101
    • 34003-Clínica Médica y Dental CLIMEDENTY
  • Tegucigalpa, Honduras, 2449
    • 34002-Inversiones en Investigación Médica (INVERIME)
• Latvia
  • Daugavpils, Latvia, LV 1004
    • 42802-OLVI Medical Centre
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • 45801-University Malaya Medical Centre
  • Perlis
    • Kangar, Perlis, Malaysia, 01000
      • 45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • 45803-Sarawak General Hospital
    • Sibu, Sarawak, Malaysia, 96000
      • 45802-Hospital Sibu
  • Wilyah Persekutuan Putrajaya
    • Putrajaya, Wilyah Persekutuan Putrajaya, Malaysia, 62250
      • 45805-Klinik Kesihatan Putrajaya Presint 9
• New Zealand
  • Christchurch, New Zealand, 8011
    • 55403-Christchurch Clinical Studies Trust
  • Wellington, New Zealand, 6021
    • 55401-Wellington Hospital
• Pakistan
  • Islamabad, Pakistan
    • 58602-Shifa International Hospital
  • Karachi, Pakistan
    • 58604-The Aga Khan
  • Lahore, Pakistan
    • 58605-Avicenna Hospital
  • Lahore, Pakistan
    • 58607-Central Park Teaching Hospital
  • Rawalpindi, Pakistan
    • 58601-Al Shifa Research Centre
• Philippines
  • Bacoor, Philippines
    • 60817-Health Index Multispecialty Clinic
  • Cebu City, Philippines
    • 60801-Chong Hua Hospital
  • Dasmariñas, Philippines
    • 60812-De La Salle Medical and Health Sciences Institute
  • Dasmariñas, Philippines
    • 60816-De La Salle Medical and Health Sciences Institute
  • Manila, Philippines, 1008
    • 60806-Mary Chiles General Hospital
  • Manila, Philippines
    • 60814-Philippine General Hospital
  • Manila, Philippines
    • 60815-Philippine General Hospital
  • Manila, Philippines
    • 60818-Philippine General Hospital
  • Quezon City, Philippines
    • 60811-UERM Memorial Medical Center
  • Quezon City, Philippines
    • 60813-Philippine Children's Medical Center
  • Manila
    • Ermita, Manila, Philippines, 1000
      • 60808-University of the Philippines Manila Development Foundation Inc
  • Quezon
    • Quezon City, Quezon, Philippines
      • 60810-UERM Memorial Medical Center
• Poland
  • Bydgoszcz, Poland, 85-090
    • 61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.
  • Dębica, Poland, 39-200
    • 61603-Jerzy Brzostek Prywatny Gabinet Lekarski
  • Gdańsk, Poland, 80-542
    • 61607-Gdanskie Centrum Zdrowia Sp. z o.o.
  • Kraków, Poland, 31-302
    • 61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska
  • Rzeszów, Poland, 35-302
    • 61608-Gabinet Lekarski Bartosz Korczowski
  • Siemianowice Śląskie, Poland, 41-103
    • 61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice
  • Skierniewice, Poland, 96-100
    • 61601-ETG Network- Skierniewice,Clinmed Research
  • Trzebnica, Poland, 55-100
    • 61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy
• Romania
  • Bucuresti, Romania, 011025
    • 64201-SC Sana Monitoring SRL.
  • Caracal, Romania, 235200
    • 64202-Spitalul Municipal Caracal
  • Călăraşi, Romania, 910160
    • 64205-Sc Med Fam Apolo srl
  • Sângeorgiu De Mureş, Romania, 547530
    • 64206-S.C Centrul Clinic Mediquest S.R.L
• South Africa
  • Brits, South Africa
    • 71006-Madibeng Centre for Research
  • Cape Town, South Africa
    • 71004-Tread Research
  • Cape Town, South Africa
    • 71007-Allergy & Immunology Unit
  • East London, South Africa
    • 71002-Synergy Biomed Research Institute
  • Klerksdorp, South Africa
    • 71009-Perinatal HIV Research Unit, Tshepong Hospital
  • Paarl, South Africa
    • 71001-Be Part Yoluntu Centre
  • Pretoria, South Africa
    • 71008-Clinical Trial Systems
  • Soweto, South Africa
    • 71003-Soweto Clinical Trials Centre
  • Thabazimbi, South Africa
    • 71005-Limpopo Clinical Research Initiative
• Thailand
  • Bangkok, Thailand, 10400
    • 76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
  • Bangkok, Thailand, 10400
    • 76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • 76405-Phramongkutklao Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58023
    • 80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU
  • Dnipro, Ukraine, 49027
    • 80405-CI Dnipro Children's City CH #5 of Dnipro City Council
  • Vinnytsia, Ukraine, 21000
    • 80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QIVc; Cell-derived Quadrivalent Influenza Vaccine	Biological: QIVc; 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.; Other Names: Flucelvax Quadrivalent
Active Comparator: Comparator; Non-influenza Comparator	Biological: Comparator; Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	>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	>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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	>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	>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	>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	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	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	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	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	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	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	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	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).	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	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)

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Clinical Program Director, Seqirus

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): February 13, 2024

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Influenza Vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: V130_14; 2018-001857-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

IPD Sharing Access Criteria

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes