Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.
Condition: Prophylaxis of A/H3N2v Influenza
MeSH terms: Influenza, Human
Intervention: Swine Influenza
Intervention description: Comparison of different dosages of vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 627.0
Sex: All
Minimum age: 3 Years
Maximum age: 92 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in
      children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly
      65 years and older.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females 3 years of age and older

          2. Individuals or, (for children and adolescents) parents or legal guardians, who have
             given written consent after the nature of the study has been explained according to
             local regulatory requirements. Assent is required depending on age of child/adolescent

          3. Individuals in good health as determined by the outcome of medical history, physical
             examination, and clinical judgment of the investigator

          4. Individuals who can comply with study procedures and are available for follow-up

        Exclusion Criteria:

          1. Individuals with behavioral or cognitive impairment, including psychiatric illness, as
             determined by the investigator's clinical judgement may interfere with the subject's
             ability to participate in study

          2. Individuals with any progressive or severe neurologic disorder, seizure disorder or
             recent history of Guillian-Barré syndrome

          3. Individuals or (for children and adolescents) parents or legal guardians who are not
             able to comprehend and to follow all required study procedures for the whole period of
             the study

          4. Individuals with a history of illness/with an ongoing illness that, in the opinion of
             the investigator, may pose additional risk to the subject if he/she participates in
             the study

          5. Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special
             interest

          6. Individuals with known or suspected impairment of the immune system including, but not
             limited to:

               -  autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or
                  agammaglobulinemia;

               -  autoimmune disorders;

               -  Systemic therapy with corticosteroids or other immunosuppressive therapy.

               -  Receipt of immunoglobulin preparation, blood products, and/or plasma derivatives
                  within 3 months prior to Day 1 or planned during the full length of the study

          7. Individuals who are pregnant or breastfeeding. Female subjects of childbearing
             potential must have a negative pregnancy test prior to study vaccines being
             administered

          8. If female, "of childbearing potential", sexually active, and has not used any of the
             "acceptable contraceptive methods" for at least 2 months prior to study entry

          9. "Of childbearing potential" is defined as status post onset of menarche and not
             meeting any of the following conditions: menopausal for at least 2 years, status after
             bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or
             status after hysterectomy

         10. Acceptable birth control methods are defined as one or more of the following:

               1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant,
                  cervical ring);

               2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time
                  during intercourse;

               3. Intrauterine device (IUD);

               4. Monogamous relationship with vasectomized partner. Partner must have been
                  vasectomized for at least six months prior to the subject's study entry.

         11. If female of childbearing potential and sexually active, refusal to use an "acceptable
             contraceptive method" through to 3 weeks after last study vaccination

         12. Individuals who are allergic to any of the vaccine components.

         13. For children 17 years of age and younger: Individuals who have had ever a malignancy

         14. For adults 18 years or older: Individuals who have had a malignancy (excluding
             nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years

         15. Individuals participating in any clinical trial with another investigational product
             30 days prior to first study visit or intent to participate in another clinical study
             at any time during the conduct of this study

         16. Individuals with a body temperature >38°C (>100.4°F) or any acute illness within 3
             days of intended study vaccination

         17. Individuals who have had a previous confirmed or suspected illness from swine flu
             (H3N2v)

         18. Individuals who have received any prior H3N2v vaccine

         19. Individuals who have received any other type of influenza vaccination (e.g.,
             "seasonal") within 14 days prior to enrolment, or who plans to receive influenza
             vaccine during the treatment phase of this study (seasonal influenza vaccination is
             allowed after Day 43/Visit 3)

         20. Individuals who received any other licensed vaccines within 2 weeks (for inactivated
             vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study or who are
             planning to receive any (non-influenza) vaccine within 4 weeks from the study vaccines

         21. Individuals who are research staff involved with the clinical study or
             family/household members of research staff

         22. Individuals with a BMI > 35 kg/m2 (adults), > 29 kg/m2 (adolescents), or > 21 kg/m2
             (children)

         23. Individuals with a history of drug or alcohol abuse within the past 2 years