Influenza Clinical Trial
Official title:
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)
Verified date | December 2008 |
Source | Nanotherapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Ministry for Health and Women |
Study type | Interventional |
The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.
Status | Completed |
Enrollment | 141 |
Est. completion date | October 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 46 Years |
Eligibility |
Inclusion Criteria: Subjects who participated in Study 810501 will be eligible for participation in the study if they: - Completed 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 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | University Hospital, Department of Clinical Pharmacology, General Hospital Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Nanotherapeutics, Inc. |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20) | 9 months | No |
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