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

NCT ID: NCT03165617

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4514 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2019-09-30

Brief 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 (Menveo®, GlaxoSmithKline Biologicals, S.A.) in healthy pediatric subjects ≥2 Years to <18 Years of Age

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").

Conditions

Influenza, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

QIVc (≥2 years to <18 Years of Age)

Cell-derived Seasonal Quadrivalent Influenza Vaccine

Group Type: EXPERIMENTAL

QIVc

Intervention Type: BIOLOGICAL

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 Vaccine

Non-Influenza Comparator Vaccine

Group Type: ACTIVE_COMPARATOR

Non-influenza Comparator Vaccine

Intervention Type: BIOLOGICAL

Non-influenza comparator vaccine for intramuscular use

Interventions

QIVc

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

Intervention Type: BIOLOGICAL

Non-influenza Comparator Vaccine

Non-influenza comparator vaccine for intramuscular use

Intervention Type: BIOLOGICAL

Other Intervention Names

Flucelvax Quadrivalent

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seqirus

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Program Director

Role: STUDY_DIRECTOR

Seqirus

Locations

302 AusTrials Pty Ltd

Sherwood, Queensland, Australia

300 Murdoch Childrens Research Institute

Carlton, Victoria, Australia

500 Merelahe Family Doctors Centre

Tallinn, Harju, Estonia

504 Merekivi Family Doctors Ltd

Tallinn, Harju, Estonia

502 Medicum AS

Tallinn, Harju, Estonia

503 Vee Family Doctors Centre

Paide, Järvamaa, Estonia

505 Clinical Research Center

Tartu, Tartu, Estonia

505 Clinical Research Center

Tartu, , Estonia

607 Espoo Vaccine Research Clinic

Espoo, , Finland

603 Helsinki South Vaccine Research Clinic

Helsinki, , Finland

604 Helsinki South Vaccine Research Clinic

Helsinki, , Finland

600 Järvenpää Vaccine Research Clinic

Järvenpää, , Finland

606 Kokkola Vaccine Research Clinic

Kokkola, , Finland

605 Oulu Vaccine Research Clinic

Oulu, , Finland

601 Pori Vaccine Research Clinic

Pori, , Finland

602 Seinäjoki Vaccine Research Clinic

Seinäjoki, , Finland

608 Tampere Vaccine Research Clinic

Tampere, , Finland

609 Turku Vaccine Research Clinic

Turku, , Finland

706 Private Office of Children Pulmonologist

Alytus, Alytus Apskritis, Lithuania

704 Kauno klinikine ligonine

Kaunas, Kaunas County, Lithuania

703 UAB InMedica

Kaunas, Kaunas County, Lithuania

702 JSC Saules seimos medicinos centras

Kaunas, Kaunas County, Lithuania

700 Kaunas Silainiai Outpatient Clinic

Kaunas, Kauno Apskrits, Lithuania

701 Naujininkai Outpatient Clinic

Vilnius, Vilnaius Apskritis, Lithuania

402 De La Salle Health Sciences Institute

Dasmariñas, Cavite, Philippines

405 De La Salle Health Sciences Institute

Dasmariñas, Cavite, Philippines

403 Philippine General Hospital

Manila, National Capital Region, Philippines

404 Philippine General Hospital

Manila, National Capital Region, Philippines

400 Research Institute For Tropical Medicine

Muntinlupa, National Capital Region, Philippines

401 Research Institute For Tropical Medicine

Muntinlupa, National Capital Region, Philippines

406 Research Institute For Tropical Medicine

Muntinlupa, National Capital Region, Philippines

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

806 Specjalistyczny Szpital im. E. Szczeklika w Tarnowie

Tarnów, Lesser Poland Voivodeship, Poland

803 Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

Trzebnica, Lower Silesian Voivodeship, Poland

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

Łęczna, Lublin Voivodeship, Poland

804 Prywatny Gabinet Lekarski

Dębica, Podkarpackie Voivodeship, Poland

NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, Silesian Voivodeship, Poland

900 Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

200 Srinagarind Hospital, Khon Kaen University

Khon Kaen, Muang, Thailand

201 ChiangMai University

Chiang Mai, , Thailand

Countries

Australia; Estonia; Finland; Lithuania; Philippines; Poland; Spain; Thailand

References

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.

Reference Type: DERIVED

PMID: 34644472 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002883-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V130_12

Identifier Type: -

Identifier Source: org_study_id