H5N1 Influenza
Conditions
Keywords
Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)
Brief summary
The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.
Interventions
BIOLOGICALH5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm
Sponsors
Baxter Innovations GmbH
Alachua Government Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 to 59 years old at the time of screening * Subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination * Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary * If female of childbearing potential, subject presents with a negative urine pregnancy test result within 24 hours prior ot the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study
Exclusion criteria
* Subject has a history of infectin with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine * Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers) * Subject currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder * Subject has any inherited or acquired immunodeficiency * Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs * Subject has a history of severe allergic reactions or anaphylaxis * Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating * Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry * Subject has donated blood or plasma within 30 days prior to study entry * Subject has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study * Subject has a functional or surgical asplenia * Subject has a known or suspected problem with alcohol or drug abuse * Subject was administered an investigational drug within 6 weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product * Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator/subinvestigator or site personnel conducting the study * If female, subject is pregnant or lactating at the time of enrollment * Subject has any other condition that disqualifies his/her participation in the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fold increase of antibody response | 21 days after 2nd vaccination | Measurement by SRH assay |
| Number of subjects with antibody response to the vaccine strain | 21 days after 2nd vaccination | Measurement by single radial hemolysis (SRH) assay |
| Number of subjects demonstrating seroconversion | 21 days after 2nd vaccination | Measurement by SRH assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with antibody response to the vaccine strain | 21 days after 1st and 21+180 days after 2nd vaccination | Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay |
| Fold increase of antibody response | 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline | Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay |
| Number of subjects demonstrating seroconversion | 21 days after 1st and 21+180 days after 2nd vaccination | Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay |
| Antibody response | 21 days after 1st and 21 + 180 days after 2nd vaccination | Measurement by SRH, MN and HI assay |
Countries
Japan
Outcome results
None listed