An Open-Label Phase III Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as well as in Specified Risk Groups - Phase III Study of a H5N1 Vaccine in Adults, Elderlys, and Specified Risk Groups.
- Conditions
- H5N1 vaccination in healthy subjects (adult and elderly population) and in specified risk groups (chronically ill, transplant and HIV patients).
- Registration Number
- EUCTR2008-000558-11-LV
- Lead Sponsor
- Baxter AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3560
The following inclusion criteria apply to subjects in all three cohorts:
Male and female subjects will be eligible for participation in this study if they:
- Are 18 years of age or older 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 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.
The following inclusion criterion applies to subjects in Cohort 1 only:
- Are generally healthy, as determined by the investigator's clinical judgment through collections of medical history and performance of a physical examination.
The following inclusion criterion applies to subjects in Cohort 2 only:
- Are immune compromised due to immunosuppressive treatment (e.g. transplant patients) or due to acquired immunodeficiency caused by HIV infection.
The following inclusion criterion applies to subjects in Cohort 3 only:
- Have a chronic cardiovascular (excluding hypertension, respiratory, renal, or metabolic (diabetes mellitus) illness.
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) yes
F.1.3.1 Number of subjects for this age range
The following exclusion criteria apply to sujects in all three cohorts:
- Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus;
- Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
- Have a history of severe allergic reactions or anaphylaxis;
- Have a rash, dermatological condition or tattoos which may interfere with injection site reation rating;
- 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 known or suspected problem with alcohol or drug abuse;
- Were administered and 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.
- If female: are pregnant or lactating.
The following exclusion criteria apply to subjects in Cohort 1 only:
- Currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, meatbolic, rheumatic, autoimmune, hematological or renal disorder;
- 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 received a blood transfusion or immunoglobulins within 90 days prior to study entry;
- Have a functional or surgcial asplenia.
The following exclusion criterion applies to subjects in Cohort 2 only:
- Are immune compromised due to HIV infection and have a CD4 count of <200x10 6/L at screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method