Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
The purpose of this study is to assess the safety and the body's immune response (body's
 defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and
 elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no
 history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old,
 and the other 200 will be greater than or equal to 65 years of age. Participants will be
 randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1
 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine
 injections on days 0 and 21 in the arm muscle. Study procedures include: medical history,
 physical exam, maintaining a memory aid, and blood sample collection. Participants will be
 involved in study related procedures for approximately 7 months.
Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause
 of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many
 countries around the world, prompting the World Health Organization (WHO) to declare a
 pandemic on June 11, 2009. Data from several cohorts in different age groups that received
 licensed trivalent seasonal influenza vaccines suggest that these vaccines are unlikely to
 provide protection against the new virus. In addition, adults are more likely to have
 measurable levels of serum hemagglutination inhibition assay (HAI) or neutralizing antibody
 than are children. These data indicate the need to develop vaccines against the new H1N1
 strain and suggest that different vaccine strategies (e.g., number of doses, need for
 adjuvant) may be appropriate for persons in different age groups. The primary safety
 objective of this study is to assess the safety of the unadjuvanted, inactivated H1N1 vaccine
 when administered at the 15 or 30 mcg dose. The primary immunogenicity objective is to assess
 the antibody response following a single dose of unadjuvanted, inactivated H1N1 vaccine,
 stratified by age of recipient, when administered at the 15 or 30 mcg dose. The secondary
 immunogenicity objective is to assess the antibody response following 2 doses of
 unadjuvanted, inactivated H1N1 vaccine, stratified by age of recipient, when administered at
 the 15 or 30 mcg dose. Participants will include up to 450 healthy adults age 18 and older
 who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009
 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and
 non-pregnant females designed to investigate the safety, reactogenicity, and immunogenicity
 of an inactivated influenza H1N1 virus vaccine at 2 dose levels. Subjects will be randomized
 into 2 dose groups, stratified by age (200 subjects per dose group with 100 subjects per age
 stratum, 18-64 or greater than or equal to 65 years of age) to receive intramuscular
 influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2). The H1N1 vaccine will be
 administered at Day 0 and Day 21. Following immunization, safety will be measured by
 assessment of adverse events through 21 days following the last vaccination (Day 42 for those
 receiving both doses and Day 21 for those who do not receive the second dose), serious
 adverse events and new-onset chronic medical conditions through 7 months post first
 vaccination (Day 201), and reactogenicity to the vaccine for 8 days following each
 vaccination (Day 0-7). Immunogenicity testing will include HAI and neutralizing antibody
 testing on serum obtained on the day of each vaccination (prior to vaccination), on Day 8-10
 after each vaccination, and 21 days following the second vaccination (Day 42).
Inclusion Criteria:

 -  Are males or non-pregnant females age 18 and older, inclusive.

 -  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.

 -  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 targeted physical examination based on medical history. 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.

 -  Are able to understand and comply with planned study procedures.

 -  Provide written informed consent prior to initiation of any study procedures.

 Exclusion Criteria:

 -  Have a known allergy to eggs or other components of the vaccine (including gelatin,
 formaldehyde, octoxinol, thimerosal, and chicken protein).

 -  Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if
 female of childbearing potential), or women who are breastfeeding.

 -  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.

 -  Have an active neoplastic disease or a history of any hematologic malignancy.

 -  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.)

 -  Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric
 diagnosis.

 -  Have been hospitalized for psychiatric illness, history of suicide attempt, or
 confinement for danger to self or others, within the past 10 years.

 -  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.

 -  Have a history of receiving immunoglobulin or other blood product within the 3 months
 prior to vaccination in this study.

 -  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 201 follow-up call - 180 days
 after the second vaccination).

 -  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.

 -  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.

 -  Have a history of severe reactions following previous immunization with influenza
 virus vaccines.

 -  Have an acute illness, including an oral temperature greater than 100.4 degrees
 Fahrenheit, within 3 days prior to vaccination.

 -  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.

 -  Participated in a novel influenza H1N1 2009 vaccine study in the past two years or
 have a history of novel influenza H1N1 2009 infection prior to enrollment.

 -  Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
 infection.

 -  Have a history of alcohol or drug abuse in the last 5 years.

 -  Plan to travel outside of North America in the time between the first vaccination and
 42 days following the first vaccination.

 -  Have a history of Guillain-Barré Syndrome.

 -  Have any condition that the investigator believes may interfere with successful
 completion of the study.