Safety, Immunogenicity, and Relative Efficacy 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.

- Satisfactory baseline medical assessment by history and physical examination.

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

- 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 demonstrated
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 A/California/7/2009 (H1N1)v-like virus
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 other than the study vaccines between Day 0 and
the phlebotomy 21 days after vaccination.

- Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the
study vaccines during the whole study (Day 0 - Day 385).

- Previous vaccination 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, although stable, are deemed by the investigator to render the potential subject
unable/unlikely to provide accurate safety reports.

- Presence of a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment
preferred, 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.

- Receipt of systemic glucocorticoids within 1month 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 are
eligible if no such doses are given in the 24 hours before a study vaccination.
Persons receiving prophylactic antiplatelet medications, e.g., low-dose
acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are
eligible.

- History of 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 vaccines
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 other than the study vaccine between Day 0 and
the phlebotomy 21 days after the second study vaccine dose.

- Use of any investigational or non-registered product within 30 days preceding the
first dose of study vaccine, 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 vaccination.

- Lactating or nursing women.