A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influsplit Tetra™ vaccine produced by investigational process (IP); Influsplit Tetra™ vaccine produced by licensed process (LP)
Intervention description: Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.; Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
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: 1886.0
Sex: All
Minimum age: 6 Months
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Quadrivalent influenza vaccine; Safety; Children; Adults; Immunogenicity

Summary:

      The purpose of this trial is to demonstrate the acceptable safety profile and the
      immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational
      process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the
      current licensed process (FLU D-QIV Licensed Process [LP]).
    

Eligibility criteria:

        Inclusion Criteria:

        Adults 18-49 years cohort:

          -  A male or female between, and including, 18 and 49 years of age at the time of
             vaccination.

          -  Subjects who the investigator believes that they/their parent(s)/Legally Acceptable
             Representatives (LAR(s)) can and will comply with the requirements of the protocol.

          -  Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.

          -  Written informed assent obtained from the subject if/as required by local regulations.

          -  Healthy subjects or those with chronic well-controlled disease as established by
             medical history and clinical examination before entering into the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.
             Non-childbearing potential is defined as pre-menarche, current tubal ligation,
             hysterectomy, ovariectomy.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject: has practiced adequate contraception for 30 days prior to vaccination, and
             has a negative pregnancy test on the day of vaccination, and has agreed to continue
             adequate contraception for 2 months after vaccination.

        Pediatric cohort:

        United States:

        • A male or female subject between, and including, the ages of 3 and 17 years in the United
        States.

        Rest of the World:

        • A male or female subject between, and including, the ages of 6 months to 17 years all
        countries with the exception of the United States.

        All participating countries:

          -  Subjects who the investigator believes that they/their parent(s)/Legally Acceptable
             Representatives (LAR(s)) can and will comply with the requirements of the protocol.

          -  Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.

          -  Written informed assent obtained from the subject if/as required by local regulations.

          -  Healthy subjects or those with chronic well-controlled disease as established by
             medical history and clinical examination before entering into the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.
             Non-childbearing potential is defined as pre-menarche, current tubal ligation,
             hysterectomy, ovariectomy.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject: has practiced adequate contraception for 30 days prior to vaccination, and
             has a negative pregnancy test on the day of vaccination, and has agreed to continue
             adequate contraception during the entire treatment period and for 2 months after
             completion of the vaccination series.

        Exclusion Criteria:

        Adults aged 18-49 years cohort:

          -  Child in care.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical or device).

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within 6 months prior to the first vaccine dose.
             Inhaled and topical steroids are allowed.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  Any administration of a long-acting immune-modifying drug within 6 months before study
             start, or planned administration during the study period.

          -  Administration of an influenza vaccine during the 6 months preceding entry into the
             study.

          -  Administration of a vaccine not foreseen by the study protocol within 30 days before
             vaccination or planned administration during the study period.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Any known or suspected allergy to any constituent of influenza vaccines (including egg
             proteins); a history of anaphylactic-type reaction to consumption of eggs; or a
             history of severe adverse reaction to a previous influenza vaccine.

          -  Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or
             renal functional abnormality, as determined by physical examination or laboratory
             tests.

          -  Any history of Guillain-Barré Syndrome.

          -  Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥
             38.0ºC/100.4ºF.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any contra-indication to intramuscular administration of influenza vaccines.

          -  Any other condition which, in the opinion of the investigator, prevents the subject
             from participating in the study.

        Pediatric cohort

          -  Child in care.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical or device).

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within 6 months prior to the first vaccination dose.
             Inhaled and topical steroids are allowed.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  Any administration of a long-acting immune-modifying drug within 6 months before study
             start, or planned administration during the study period.

          -  Administration of an influenza vaccine during the 6 months preceding entry into the
             study.

          -  Administration of a vaccine not foreseen by the study protocol within 30 days before
             vaccination or planned administration during the study period.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Any known or suspected allergy to any constituent of influenza vaccines (including egg
             proteins); a history of anaphylactic-type reaction to consumption of eggs; or a
             history of severe adverse reaction to a previous influenza vaccine.

          -  Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or
             renal functional abnormality, as determined by physical examination or laboratory
             tests.

          -  Any history of Guillain-Barré Syndrome.

          -  Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥
             38.0ºC/100.4ºF.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any contra-indication to intramuscular administration of influenza vaccines.

          -  Any other condition which, in the opinion of the investigator, prevents the subject
             from participating in the study.