A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Seqirus Quadrivalent Inactivated Influenza Vaccine; Comparator Quadrivalent Inactivated Influenza Vaccine
Intervention description: The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.; The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2250.0
Sex: All
Minimum age: 6 Months
Maximum age: 59 Months
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 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric
      population 6 months through 59 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject 6 months through to 59 months of age at the time of first
             vaccination and born between 36 and 42 weeks of gestation;

          -  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.

          -  Subject is in generally good health as per the Investigator's medical judgment

        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 such as
             encephalomyelitis and transverse myelitis;

          -  History of licensed or investigational influenza vaccination in the last 6 months;

          -  Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥
             37.5 °C) on the day of vaccination 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

          -  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

          -  Current or medical history of malignant neoplasms;

          -  Administration of immunoglobulin and/or any blood products within the previous 90 days
             preceding the administration of the Study Vaccine or planned administration during the
             study;

          -  Participation in a clinical trial or use of an investigational compound within 28 days
             prior to or 28 days after receiving the Study Vaccine, or plans to enter a study
             during this period;

          -  Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior
             to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the
             Study Exit Visit.

          -  Medical conditions or treatment contraindicating intramuscular vaccination due to
             increased risk of bleeding.

          -  Family members of the employees of the Investigator or study center with direct
             involvement in the study, or with other clinical studies under the direction of that
             Investigator or study center.