H5N1 vaccination with a single Prime-Boost Vaccination schedule in healthy subjects aged 18 to 59 years. MedDRA version: 9.1 Level: LLT Classification code 10059430 Term: Influenza immunization
Conditions
Interventions
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects will be eligible for participation in this study if they: • Are 18 to 59 years of age, inclusive, on the day of screening; • Have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry; • Are generally healthy, as determined by the investigator’s clinical judgment through collection of medical history and performance of a physical examination. • Are physically and mentally capable of participating in the study and follow its procedures; • Agree to keep a daily record of symptoms for the duration of the study; • If female of childbearing potential – have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participation in this study if they: • Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine; • Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers); • Currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorders; • Have any inherited or acquired immunodeficiency; • Have a disease or are currently undergoing a form of treatment or were 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 high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs; • Have a history of severe allergic reactions or anaphylaxis; • Have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating; • Have received any blood products or immunoglobulins within 90 days prior to study entry; • Have donated blood or plasma within 30 days prior to study entry; • Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study; • Have a functional or surgical asplenia; • Have a known or suspected problem with alcohol or drug abuse; • Were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product; • Are a member of the team conducting this study or are 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 or site personnel conducting the study; • If female: are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Immunogenicity: • Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination defined as titer measured by Microneutralization (MN) test = 1:20.;Main Objective: -immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule; - persistence of H5N1 influenza antibodies after vaccination with a non-adjuvanted H5N1 influenza vaccine - safety and tolerability of a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule; Primary Immunogenicity: Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination defined as titer measured by Microneutralization (MN) test = 1:20. Please note that the priming vaccination will contain H5N1 HA antigen strain A/Vietnam/1203/2004 in a non-adjuvanted formulation. The booster vaccination will contain H5N1 HA antigen strain A/Indonesia/05/2005 in a non-adjuvanted formulation. ;Secondary Objective: Immungenicity: •Number of subjects with antibody response associated with protection 21, 42, 180 and 360 days after the priming vaccination as measured by MN assay; •Antibody response 21, 42, 180 and 360 days after the priming vaccination and 21 days after the booster vaccination; •Fold increase of antibody response 21 and 42 days after the priming vaccination as compared to baseline, and 21 days after the booster vaccination as compared to prior to the booster vaccination; •Number of subjects: - demonstrating seroconversion - with antibody response associated with protection 180 days after the booster vaccination Safety: •Frequency and severity of systemic reactions and injection site reactions until 21 days after the priming and booster vaccination. •Number of subjects with fever, malaise or shiv | — |
Countries
Austria, Finland
Outcome results
None listed