Influenza
Conditions
Keywords
Pandemic influenza
Brief summary
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.
Interventions
BIOLOGICALH5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted
All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.
Sponsors
Alachua Government Services, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 46 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria
Outcome results
None listed