A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Seqirus QIV; Comparator QIV
Intervention description: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.; The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2278.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to assess the immune (antibody) response and safety of a Seqirus split
      virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US
      licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric
      population 5 through 17 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 5 through 17 years of age on the day of first study vaccination.

          -  Parent or legally acceptable representative able to provide written informed consent
             and be willing and able to adhere to all protocol requirements including blood draws.
             Participant assent will also be obtained if required.

          -  If applicable, females of childbearing potential (ie, ovulating, not surgically
             sterile) must be abstinent or be willing to use a medically accepted contraceptive
             regimen until at least 28 days after the last Study Vaccine. Females of childbearing
             potential must return a negative urine pregnancy test result, prior to any vaccination
             dose with the Study Vaccine.

        Exclusion Criteria:

          -  History of allergic reactions to egg proteins or any components of the Study Vaccines.

          -  History of serious adverse reactions to any influenza vaccines.

          -  History of Guillain-Barré syndrome or other demyelinating disease.

          -  History of licensed or investigational influenza vaccination in the last 6 months.

          -  Clinical signs of active infection and/or an oral temperature of ≥ 100°F (37.8°C) on
             the day of planned Study Vaccine administration or within 48 hours preceding
             vaccination.

          -  Current or recent, acute or chronic medical conditions that in the opinion of the
             Investigator are clinically significant and/or unstable (such as illness
             exacerbations) within the preceding 30 days.

          -  History of any seizures, with the exception of a single febrile seizure.

          -  Self-reported or known seropositivity suggestive of acute or chronic viral infection
             for human immunodeficiency virus, hepatitis B or hepatitis C.

          -  Known or suspected congenital or acquired immunosuppressive conditions.

          -  Current or recent immunosuppressive or immunomodulatory therapy, as follows:

               -  Chronic or long-term systemic corticosteroids: ≥ 0.125 mg/kg/day of oral
                  prednisolone or equivalent daily;

               -  Sporadic systemic corticosteroids: ≥ 0.5 mg/kg/day of oral prednisolone or
                  equivalent for two or more short courses of > 3 days in the 3 months preceding
                  vaccination;

               -  Antineoplastic chemotherapy or radiation therapy within the 6 months preceding
                  vaccination.

        Note: Use of topical, inhalant or localised tissue injections of corticosteroids prior to
        administration of the Study Vaccine or throughout the study are acceptable.

          -  Administration of immunoglobulin and/or any blood products within the 3 months
             preceding vaccination, or planned administration during the study.

          -  Participation in a clinical trial or use of an investigational compound within 28 days
             prior to the first dose of Study Vaccine, or within 28 days after receiving the final
             indicated dose of Study Vaccine, or plans to enter a study during this period.

          -  Vaccination with a licensed vaccine 28 days (for live or inactivated vaccines) prior
             to receiving the first dose of Study Vaccine, or plans to receive any licensed vaccine
             prior to the Study Exit Visit.

          -  Pregnant or lactating females.