Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
Intervention description: 0.25 mL Intramuscular (2 doses given 28 days apart); 0.5 mL Intramuscular; 0.5 mL Intramuscular; 0.5 mL Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 602.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Trivalent influenza vaccine; Sanofi Pasteur Shenzhen trivalent influenza vaccine

Summary:

      The main purpose of this trial is to describe the product profile in terms of immunogenicity
      and safety following administration of trivalent influenza vaccine (split-virion,
      inactivated) produced at Shenzhen (SP Shz TIV).

      Primary objective:

        -  To describe in each group the immune response induced by a single dose (subjects aged ≥
           3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.

      Secondary objective:

        -  To describe in each group the safety profile of the vaccine after a single dose
           (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35
           months).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 6 months on the day of inclusion

          -  Informed Consent Form has been signed and dated:

               -  by the parent(s) or legally acceptable representative, if applicable, for
                  subjects <18 years of age. Additionally, an assent form has been signed by the
                  subject if aged 10 to 17 years (based on local regulations).

               -  by the subject himself/herself for subjects ≥18 years of age.

          -  Subject and parent(s)/legally acceptable representative (if applicable) are able to
             attend all scheduled visits and to comply with all trial procedures

          -  For subjects aged 6-35 months only: Born at full term of pregnancy (≥37 weeks) and
             with a birth weight ≥2.5 kg

          -  For subjects aged 3-8 years only: Subject has previously received at least one dose of
             influenza vaccine in the past years or has a history of prior exposure to influenza
             virus through natural infection.

        Exclusion Criteria:

          -  Subject is pregnant (positive urine pregnancy test), or lactating, or of childbearing
             potential (to be considered of non-childbearing potential, a female must be
             pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an
             effective method of contraception or abstinence from at least 4 weeks prior to
             vaccination and until at least 4 weeks after vaccination)

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first
             trial vaccination) or planned participation during the present trial period in another
             clinical trial investigating a vaccine, drug, medical device, or medical procedure

          -  Receipt of any vaccine or planned receipt of any vaccine within the period from 2
             weeks before to 2 weeks after trial vaccination (subjects aged ≥3 years) or within the
             period from 2 weeks before the first trial vaccination to 2 weeks after the second
             trial vaccination (subjects aged 6-35 months)

          -  For subjects aged 6-35 months only: Previous vaccination against influenza (i.e. 2
             consecutive doses of influenza vaccine [same seasonal strain composition]) any time
             prior to study enrollment or history of prior exposure to influenza virus through
             natural infection

          -  Vaccination against influenza given in the past 6 months with any influenza vaccine or
             planned receipt of influenza vaccination during the present study

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months,
             which might interfere with assessment of the immune response

          -  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)

          -  Reported history of seropositivity for Human Immunodeficiency Virus (HIV), after
             questioning the subject or the subject's parents or another legally acceptable
             representative

          -  Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and
             octoxynol-9, or to any of the vaccine components, or history of a life-threatening
             reaction to the vaccine used in the study or to a vaccine containing any of the same
             substance

          -  Self-reported thrombocytopenia, as reported by the subject, parent or legally
             acceptable representative contraindicating intramuscular vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination upon investigator's judgment

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol abuse or drug addiction that might interfere with the ability to
             comply with trial procedures

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (axillary temperature ≥37.1°C). A prospective
             subject should not be included in the study until the condition has resolved or the
             febrile event has subsided

          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first
             blood draw

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.