avian influenza
Conditions
Interventions
Product Name: Fluad H5N1
Pharmaceutical Form: Suspension for injection
Product Name: Fluad H5N1
Pharmaceutical Form: Suspension for injection
Product Name: Plain H5N1 vaccine
Product Code: plain vac
Sponsors
University Hospitals Of Leicester NHS Trust, Gwendolen Road
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Subjects 18 to 59 years of age, or 60 years of age and older, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol; 2. Are in good health or have one or more stable (See footnote) medical conditions, as determined by: a. Medical history, b. Physical examination, c. Clinical judgment of the medical investigator; 3. Are able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits. 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
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Receipt of another investigational agent within 3 months, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study; 2. Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) during the 7 days preceding vaccination; 3. Subjects who experienced fever (defined as axillary temperature >=38C) within 3 days prior to Visit 1; 4. Subjects who are pregnant or breastfeeding; 5. Females of childbearing potential who refuse to use an acceptable method of birth control for a period of 56 days before and after each vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), monogamous relationship with vasectomised partner who has been vasectomised for 6 months or more prior to the subject’s study entry, or abstain from heterosexual intercourse (e.g., through sexual orientation or religious or other beliefs about premarital intercourse); 6. Subjects with any serious disease, including: a. cancer, b. acute or progressive hepatic disease, c. acute or progressive renal disease, d. chronic pulmonary disease requiring home oxygen therapy, e. active neurological disorder, f. autoimmune disease (including rheumatoid arthritis); 7. Subjects for whom surgery is planned during the study period; 8. Subjects with a bleeding diathesis; 9. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymixin, or any other component of the study vaccine; 10.Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine; 11. Subjects with known or suspected impairment/alteration of immune function, for example, resulting from: a. receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or cancer chemotherapy) (long-term, inhaled steroids for asthma management is acceptable), b. receipt of immunostimulants or interferon, c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5 (Day 382), or planned during the full length of the study, d. high risk from developing an immunocompromising disease; 12. Actual or planned receipt of another vaccine during the period 3 weeks before to 3 weeks after vaccination on Days 1, 22, and 382; 13. Subjects with a history of (or current) drug or alcohol abuse (20g/day for females; 30g/day for males) that in the investigator’s opinion would interfere with safety of the subject or the evaluation of the study objectives; 14. Subjects who are unable to lead an independent life either physically or mentally; 15. Have participated in a previous study of H5 avian influenza vaccine; 16. Have been previously vaccinated with a vaccine containing MF59 or similar adjuvant; 17. Subjects with any co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic. The purpose of the study is to examine the height, breadth (i.e., cross-protective antibosy responses), and persistence of the antibody response to a prime-boost vaccination strategy, and establish whether the response after boosting depnds on whether the booster is adjuvanted or not. The ultimate goal of this work is to provide crucial infromation on the use of pre-pandemic vaccines in priming and protecting the population from pandemic influenza, specifically paying attention to ways in which the least amount of antigen can immunise the largest number of people.;Secondary Objective: To evaluate the magnitude of the antibody responses to one or two ‘priming’ 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 influenza vaccine in immunologically naïve subjects; To examine the kinetics, magnitude, breadth, and persistence of the antibody responses to one 0.5mL ‘booster’ intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75 or 7.5µg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine; To evaluate the safety of the administration of the above vaccines.;Primary end point(s): Antibody response and persistence after primary and booster immunizations | — |
Countries
United Kingdom
Outcome results
None listed