Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated); High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated); High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated); Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated); FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)
Intervention description: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Solution for injection Route of administration: IM; Pharmaceutical form: Solution for injection Route of administration: IM
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study was divided into 13 groups and enrolled participants in 4 stages. The study used a stepwise age de-escalation and dose ascension design for children 6 months to less than (<) 5 years of age.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Modified double-blind: the participant's parent / legally acceptable representative, the Investigator, and other study personnel remained unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.
Enrollment: 665.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this study were:

        -  To describe the safety of each dosage of high-dose quadrivalent influenza vaccine
           (QIV-HD) used in the study during the 28 days following each vaccination, and serious
           adverse events (including adverse events of special interest throughout the study).

        -  To describe the antibody response induced by each dosage of QIV-HD used in the study
           compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by
           hemagglutination inhibition (HAI) measurement method.

        -  To describe the antibody response induced by each dosage of QIV-HD used in the study
           compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method.

        -  To describe the antibody response induced by the highest acceptable dosage of QIV-HD
           compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN
           measurement methods.
    

Eligibility criteria:

        Inclusion criteria :

          -  Aged 6 months to 17 years on the day of inclusion.

          -  Assent form was signed and dated by the participant (7 to 17 years of age) and
             informed consent form was signed and dated by the parent(s) or guardian(s) and by an
             independent witness, if required by local regulations.

          -  Participant and parent/guardian were able to attend all scheduled visits and complied
             with all study procedures.

          -  For participants aged <24 months: Born at full term of pregnancy (greater than or
             equal to [>=] 37 weeks) and/or with a birth weight >=2.5 kilogram.

        Exclusion criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential and not using an
             effective method of contraception or abstinence from at least 4 weeks prior to
             vaccination until at least 4 weeks after vaccination. To be considered of
             non-childbearing potential, a female must be pre-menarche.

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first
             study vaccination) or planned participation during the present study period in another
             clinical study investigating a vaccine, drug, medical device, or medical procedure.

          -  Receipt of any vaccine in the 30 days preceding the first study vaccination, or
             planned receipt of any vaccine before Visit 3 for participants receiving 1 dose of
             influenza vaccine or Visit 5 for participants receiving 2 doses of influenza vaccine.

          -  For previously influenza vaccinated participants: Previous vaccination against
             influenza in the preceding 6 months with either the study vaccine or another vaccine.

          -  For previously influenza unvaccinated participants: Any influenza vaccination (from
             birth to the day of inclusion) with either the study vaccine or another influenza
             vaccine.

          -  For previously influenza unvaccinated participants: Any previous laboratory confirmed
             influenza infection (from birth to the day of inclusion)

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the preceding 6 months; or long-term systemic corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccines used in the study or to a vaccine containing
             any of the same substances.

          -  Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on
             Investigator's judgement.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction.

          -  Chronic illness that, in the opinion of the investigator, was at a stage where it
             might interfere with study conduct or completion.

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature >=38.0°Celsius
             [>=100.4°Fahrenheit]). A prospective participant should not be included in the study
             until the condition had resolved or the febrile event had subsided.

          -  Identified as an immediate family member (i.e., spouse, natural or adopted child,
             grandchild, nephew, or niece) of the Investigator or employee with direct involvement
             in the proposed study.

          -  Personal history of Guillain-Barré syndrome.

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             participant if enrolled or could interfere with the evaluation of the vaccine

          -  Personal history of clinically significant development delay (at the discretion of the
             Investigator), neurologic disorder, or seizure disorder.

          -  Known seropositivity for hepatitis B or hepatitis C.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.