Influenza, Human

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

NCT03165617 | PHASE 3 | INTERVENTIONAL

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

40 Sites

4514 Participants

Recruiting

2 Years to 17 Years

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Find closest sites:

SUBMIT

AusTrials Pty Ltd

Sherwood,Queensland,Australia,4075

Murdoch Childrens Research Institute

Carlton,Victoria,Australia,3010

Merelahe Family Doctors Centre

Tallinn,Harjumaa,Estonia,10617

Merekivi Family Doctors Ltd

Tallinn,Harjumaa,Estonia,10617

Medicum AS

Tallinn,Harjumaa,Estonia,13619

Vee Family Doctors Centre

Paide,Järvamaa,Estonia,72713

Clinical Research Center

Tartu,Tartumaa,Estonia,50106

Clinical Research Center

Tartu,Estonia

Espoo Vaccine Research Clinic

Espoo,Finland

Helsinki South Vaccine Research Clinic

Helsinki,Finland

Helsinki South Vaccine Research Clinic

Helsinki,Finland

Jrvenp Vaccine Research Clinic

Järvenpää,Finland

Kokkola Vaccine Research Clinic

Kokkola,Finland,67100

Oulu Vaccine Research Clinic

Oulu,Finland

Pori Vaccine Research Clinic

Pori,Finland

Seinjoki Vaccine Research Clinic

Seinäjoki,Finland

Tampere Vaccine Research Clinic

Tampere,Finland

Turku Vaccine Research Clinic

Turku,Finland

Private Office of Children Pulmonologist

Alytus,Alytus Apskritis,Lithuania,62142

Kauno klinikine ligonine

Kaunas,Kauno Apskritis,Lithuania,47116

UAB InMedica

Kaunas,Kauno Apskritis,Lithuania,48259

JSC Saules seimos medicinos centras

Kaunas,Kauno Apskritis,Lithuania,49449

Kaunas Silainiai Outpatient Clinic

Kaunas,Kauno Apskrits,Lithuania,48259

Naujininkai Outpatient Clinic

Vilnius,Vilnaius Apskritis,Lithuania,02169

De La Salle Health Sciences Institute

Dasmarinas,Cavite,Philippines,4114

De La Salle Health Sciences Institute

Dasmarinas,Cavite,Philippines,4114

Philippine General Hospital

Manila,National Capital Region,Philippines,1000

Philippine General Hospital

Manila,National Capital Region,Philippines,1000

Research Institute For Tropical Medicine

Muntinlupa,National Capital Region,Philippines,1781

Research Institute For Tropical Medicine

Muntinlupa,National Capital Region,Philippines,1781

Research Institute For Tropical Medicine

Muntinlupa,National Capital Region,Philippines,1781

Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

Trzebnica,Dolnoslaskie,Poland,55-100

Szpital Uniwersytecki nr im. dr. Jana Biziela w Bydgoszczy

Bydgoszcz,Kujawsko-pomorskie,Poland,85-168

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

Leczna,Lubelskie,Poland,21-010

Specjalistyczny Szpital im. E. Szczeklika w Tarnowie

Tarnow,Malopolskie,Poland,33-100

Prywatny Gabinet Lekarski

Debica,Podkarpackie,Poland,39-200

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Slaskie,Slaskie,Poland,41-103

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela,A Coruña,Spain,15706

Srinagarind Hospital, Khon Kaen University

Khon Kaen,Muang,Thailand,40002

ChiangMai University

Chiang Mai,Thailand,50200

Study 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
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Additional Studies

Additional studies can be found at ClinicalTrials.gov