Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pandemic Influenza

In brief

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.

Key facts

Study ID

NCT00519389

Run by

Novavax

People needed

230

Starts

2007-07-01

Expected to finish

2008-11-01

Last updated by the study team

2013-06-21

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female 18 to 40 years of age at the time of the vaccination.
• Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
• Available by telephone.
• Free of obvious health problems as established by medical history and clinical examination before entering the study.
• If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
• Must provide written, informed consent.

You may not qualify if…

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
• Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
• Has received any influenza vaccine within the prior 12 month period.
• Has received any investigational vaccine designed for protection against avian influenza.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
• Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
• Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.

Where it is running

• Healthcare Discoveries, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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