Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: QIVc; Non-influenza Comparator Vaccine
Intervention description: 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 for intramuscular use
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 3/4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4514.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

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
    

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.