AN OPEN-LABEL PHASE II STUDY TO ASSESS THE IMMUNOGENICITY AND SAFETY OF A BOOSTER VACCINATION WITH A HETEROLOGOUS VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE IN A HEALTHY YOUNG ADULT POPULATION (FOLLOW UP TO STUDY 810501) - INACTIVATED A/H5N1/INDONESIA/05/2005 INFLUENZA VACCINE
- Conditions
- Prophylaxis of H5N1 influenza infection in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidanceMedDRA version: 9.1Level: LLTClassification code 10022000Term: Influenza
- Registration Number
- EUCTR2007-002894-30-AT
- Lead Sponsor
- Baxter AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 141
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
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
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