Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age

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

Inclusion Criteria:

- Male or female children 6 months to less than 9 years of age at the time of the first
vaccination.

- Written informed consent obtained from the subject's parent/ legally acceptable
representative (LAR); written informed assent obtained from the subject if
appropriate.

- Good general health as established by medical history and clinical examination before
entering into the study.

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

- Parent/ LAR access to a consistent means of telephone contact, land line or mobile,
but NOT a pay phone or other multiple-user device.

- Subjects who the investigator believes that their parent(s)/ LAR can and will comply
with the requirements of the protocol.

- Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the
study.

Exclusion Criteria:

- 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, even if stable, are deemed by the investigator to render the potential subject
or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.

- Presence of a temperature >= 38.0ºC (>=100.4ºF) by any route or method, 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 1 month prior to study enrollment, or any
other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Topical, intra-articular or inhaled glucocorticoids 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.

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

- Administration of any licensed vaccine within 4 weeks before the first dose of study
vaccine, with the exception of seasonal influenza vaccine.

- Planned administration of any vaccine not foreseen by the study protocol between Day 0
and the Day 42 phlebotomy, including seasonal influenza vaccine. Routine childhood
vaccinations are exempted if they cannot be delayed, but they must not be administered
on the same day as the H1N1 vaccine candidate.

- 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, 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.

- Child in care.