Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older

Collaborators: United States Department of Health and Human Services, Office of Biomedical
Advanced Research and Development Authority

Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of
the protocol.

- Written informed consent obtained from the subject.

- Male and female adults, >= 18 years of age at the time of the first vaccination.

- Safety laboratory test results within the parameters specified in the protocol.

- Satisfactory baseline medical assessment by history and physical examination.

- Comprehension of the study requirements, ability to comprehend and comply with
procedures for collection of safety data, expressed availability for the required
study period, and ability and willingness to attend scheduled visits as documented by
signature on the informed consent document.

- Access to a consistent means of telephone contact, which may be either in the home or
at the workplace, land line or mobile, but NOT a pay phone or other multiple-user
device.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- has practiced adequate contraception for 30 days prior to vaccination, and

- has a negative pregnancy test on the day of first vaccination, and

- has agreed to continue adequate contraception during the entire treatment period and
for 2 months after completion of the vaccination series.

Exclusion Criteria:

- Medical history of physician-confirmed infection with an A/California/7/2009
(H1N1)v-like virus

- Previous vaccination at any time with an H1N1v-like virus vaccine or a medical history
of physician-confirmed infection with an H1N1v-like virus.

- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses
which, even if stable, are deemed by the investigator to render the potential subject
unable/unlikely to provide accurate safety reports.

- Presence of a temperature >= 38.0ºC (>=100.4ºF), or acute symptoms greater than "mild"
severity on the scheduled date of first vaccination.

- Diagnosed with cancer, or treatment for cancer, within 3 years.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).

- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any
other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin
inhibitors or imiquimod are allowed.

- Receipt of any immunoglobulins and/or any blood products within 3 months of study
enrollment or planned administration of any of these products during the study period.

- Any significant disorder of coagulation or treatment with warfarin derivatives or
heparin. Persons receiving individual doses of low molecular weight heparin outside of
24 hours prior to vaccination, are eligible. Persons receiving prophylactic
antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a
clinically-apparent bleeding tendency, are eligible.

- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6
weeks of receipt of seasonal influenza vaccine

- With the exception of seasonal influenza vaccination, administration of any vaccine(s)
within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be
administered up to 14 days prior to study vaccination on Day 0.

- Planned administration of any vaccine not foreseen by the study protocol between Day 0
and the Day 42 phlebotomy, including seasonal influenza vaccine or a monovalent
pandemic H1N1 vaccine other than the study vaccines.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine/product, or
planned use during the study period.

- Any known or suspected allergy to any constituent of influenza vaccines; a history of
anaphylactic-type reaction to any constituent of influenza vaccines; or a history of
severe adverse reaction to a previous influenza vaccine.

- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result
prior to the first vaccination.

- Lactating or nursing women.