Study of Quadrivalent Influenza Vaccine Among Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative; Investigational Trivalent Inactivated Influenza Vaccine, No Preservative; Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative; Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
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: 739.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Quadrivalent Inactivated Influenza Vaccine; Trivalent Inactivated Influenza Vaccine; Influenza viruses

Summary:

      The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the
      licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the
      investigational TIV containing the alternate B strain in adult subjects.

      Primary Objective:

        -  To demonstrate non-inferiority of antibody responses to QIV compared with licensed
           2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the
           alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the
           four virus strains separately among subjects 65 years of age and older

      Observational Objective:

        -  To describe the safety profiles of TIV among subjects 18 years of age and older and QIV
           in subjects 65 years and older, as assessed by solicited injection site and systemic
           adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events
           collected from 21 days post-vaccination, and adverse events of special interest and
           serious adverse events (SAEs) collected from Visit 1 to Visit 2.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subject is 18 years of age or older on the day of inclusion.

          -  Informed consent form (ICF) has been signed and dated.

          -  Able to attend all scheduled visits and to comply with all trial procedures.

          -  For a woman of childbearing potential, use of an effective method of contraception or
             abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks
             post-vaccination.

        Exclusion criteria:

          -  Known pregnancy, or a positive urine pregnancy test.

          -  Currently breastfeeding a child.

          -  History of serious adverse reaction to any influenza vaccine.

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination.

          -  Planned receipt of any vaccine between Visit 1 and Visit 2.

          -  Participation in another interventional clinical trial investigating a vaccine, drug,
             medical device, or medical procedure in the 4 weeks preceding the first study
             vaccination or during the course of the study.

          -  Receipt of any influenza vaccine since 01 August 2010 (including 2009 H1N1 monovalent
             vaccine).

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
             containing any of the same substances.

          -  Receipt of blood or blood-derived products in the past 3 months, which might interfere
             with assessment of the immune response.

          -  Thrombocytopenia, bleeding disorder, or receipt of anticoagulants contraindicating
             intramuscular vaccination.

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             subject if enrolled or could interfere with the evaluation of the vaccine.

          -  Personal history of Guillain-Barré Syndrome (GBS).

          -  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).

          -  Any chronic illness that, in the opinion of the Investigator, is not well controlled
             or that may interfere with trial conduct or completion or with assessment of adverse
             events.

          -  Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis
             C.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol or drug use that, in the opinion of the Investigator, might interfere
             with the ability to comply with trial procedures.

          -  Identified as employees of the Investigator or study center, with direct involvement
             in the proposed study or other studies under the direction of that Investigator or
             study center, as well as family members (i.e., immediate, husband, wife and their
             children, adopted or natural) of the employees or the Investigator.