Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: AS03; Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Intervention description: AS03 adjuvant administered with 3.75, 7.5, or 15 mcg inactivated H1N1 vaccine.; Inactivated influenza H1N1 vaccine with AS03 adjuvant, delivered intramuscularly (IM) as 3.75, 7.5, or 15 micrograms per dose; and inactivated influenza H1N1 vaccine without adjuvant, delivered intramuscularly as 7.5 or 15 micrograms per dose. All doses of the vaccine with or without adjuvant will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 789.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1, influenza A viruses, vaccine, elderly

Summary:

      The purpose of this study is to see how the body reacts to different strengths of the H1N1
      flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may
      cause the body to produce more antibodies when it is given with a vaccine. This study will
      also compare how age affects the body's response to the H1N1 flu shot. In this study, 3
      strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2
      strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the
      same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will
      include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250
      individuals greater than or equal to age 65. Study procedures include: physical exam, blood
      samples, completing a memory aid to record vaccine side effects, medications and daily oral
      temperature. Participants will be involved in study related procedures for up to 13 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are males or non-pregnant females age 18 and older, inclusive.

          2. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral
             oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal
             to 1 year) must agree to practice adequate contraception that may include, but is not
             limited to, abstinence, monogamous relationship with vasectomized partner, barrier
             methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed
             hormonal methods during the study for at least 30 days following the last vaccination.

          3. Are in good health, as determined by vital signs, medical history to ensure any
             existing medical diagnoses or conditions are stable and not considered clinically
             significant, and limited physical examination. A stable chronic medical condition is
             defined as no change in prescription medication, dose, or frequency of medication in
             the last 3 months and health outcomes of the specific disease are considered to be
             within acceptable limits in the last 6 months. Any change that is due to change of
             health care provider, insurance company etc, or that is done for financial reasons, as
             long as in the same class of medication will not be considered a violation of this
             inclusion criterion. Any change in prescription medication due to improvement of a
             disease outcome will not be considered a violation of this inclusion criterion.

          4. Have alanine aminotransferase (ALT) within normal range per local or site laboratory
             reference ranges.

          5. Are able to understand and comply with planned study procedures.

          6. Provide written informed consent prior to initiation of any study procedures.

        Exclusion Criteria:

          1. Have a known allergy to eggs or other components of the vaccine (including squalene
             based adjuvants, gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein).

          2. Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if
             female of childbearing potential), or women who are breastfeeding.

          3. Have immunosuppression as a result of an underlying illness or treatment, or use of
             anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36
             months.

          4. Have an active neoplastic disease or a history of any hematologic malignancy.

          5. Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled
             steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the
             preceding 6 months. (Nasal and topical steroids are allowed.)

          6. Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric
             diagnosis.

          7. Have been hospitalized for psychiatric illness, history of suicide attempt, or
             confinement for danger to self or others, within the past 10 years.

          8. Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol,
             molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone,
             mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine,
             perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium
             carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug
             and are stable for at least 3 months prior to enrollment, without de-compensating
             symptoms will be allowed to be enrolled in the study.

          9. Have a history of receiving immunoglobulin or other blood product within the 3 months
             prior to vaccination in this study.

         10. Received an experimental agent (vaccine, drug, biologic, device, blood product, or
             medication) within 1 month prior to vaccination in this study or expect to receive an
             experimental agent during this study (prior to the Day 386 clinic visit - 365 days
             after the second vaccination).

         11. Have received any live licensed vaccines within 4 weeks or inactivated licensed
             vaccines within 2 weeks prior to vaccination in this study or plan receipt of such
             vaccines within 21 days following the second vaccination. This is inclusive of
             seasonal influenza vaccines.

         12. Have an acute or chronic medical condition that, in the opinion of the investigator,
             would render vaccination unsafe, or would interfere with the evaluation of responses.

         13. Have a history of severe reactions following previous immunization with influenza
             virus vaccines.

         14. Have an acute illness, including an oral temperature greater than 100.4 degrees
             Fahrenheit, within 3 days prior to vaccination.

         15. Have any condition that would, in the opinion of the site investigator, place them at
             an unacceptable risk of injury or render them unable to meet the requirements of the
             protocol.

         16. Participated in a novel influenza H1N1 2009 vaccine study in the past 2 years or have
             a history of novel influenza H1N1 2009 infection prior to enrollment.

         17. Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
             infection or autoimmune hepatitis.

         18. Have a history of alcohol or drug abuse in the last 5 years.

         19. Plan to travel outside of North America in the time between the first vaccination and
             42 days following the first vaccination.

         20. Have a history of Guillain-Barré Syndrome.

         21. Have any condition that the investigator believes may interfere with successful
             completion of the study.