Prophylaxis of H5N1 influenza infection in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance MedDRA version: 9.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Product Name: n.a.
Product Code: n.a.
Pharmaceutical Form: Suspension for injection
Concentration type: equal
Sponsors
Baxter AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Completed through the Day 42 visit in study 810501 Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry Are clinically healthy, as determined by the Investigator’s clinical judgment through collection of medical history and performance of a physical examination Agree to keep a daily record of symptoms for the duration of the study If female and capable of bearing children – have a negative urine pregnancy test result at study entry 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: Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501 Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501 Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501 Are unable to lead an independent life as a result of either physical or mental handicap Suffer from any kind of immunodeficiency since the second vaccination in Study 810501 Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently undergoing a form of treatment 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 had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501 Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating Have undergone systemic corticoid therapy within 30 days prior to study entry Have a functional or surgical asplenia Have a known or suspected problem with alcohol or drug abuse Were administered an investigational drug within six 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 the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator If female: are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine (A/Indonesia/05/2005) 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted A/Vietnam/1203/2004 H5N1 influenza vaccine in a healthy young adult population ;Secondary Objective: Assess the H5N1 influenza antibody persistence 180 days after a booster vaccination with a non-adjuvanted H5N1 influenza vaccine (A/Indonesia/05/2005) 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted A/Vietnam/1203/2004 H5N1 influenza vaccine in a healthy young adult population ;Primary end point(s): Primary Immunogenicity Endpoint 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 either Hemagglutination Inhibition Antibody (HIA) titer ³ 1:40 or titer measured by Microneutralization (MN) test ³ 1:20 Primary Safety Endpoint Number of subjects with systemic reactions after the booster vaccination | — |
Countries
Austria
Outcome results
None listed