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Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine
Bu çalışma, önce canlı zayıflatılmış, ardından inaktive (etkisizleştirilmiş) evrensel grip aşılarının güvenliğini ve bağışıklık yanıtı oluşturma özelliğini (immünojenite) incelemektedir. 18-39 yaş arası, sağlıklı gönüllüler için tasarlanmıştır. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination prior to vaccination. * In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the subject prior to performance of any study specific procedure. * Male or non-pregnant female between, and including, 18 and 39 years of age at the time of the first vaccination. * Healthy subjects without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality\*. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential must have a negative pregnancy test within 24 hours of vaccination. * Female subjects of childbearing potential must have practiced adequate contraception for 30 days prior to first vaccination and agree to continue adequate contraception until 2 months after completion of the vaccination series (Month 5). * Male subjects must be surgically sterile (e.g., vasectomy) or agree to practice adequate contraception from the first vaccination until 2 months after completion of the vaccination series (Month 5). Please refer to the glossary of terms for the definition of adequate contraception. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Medically diagnosed deviated nasal septum or nasal obstruction. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months before the first dose. * Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months before the first dose (Visit 03), or planned administration any time during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose (Visit 03) up to Month 15 (Visit 15) * Persons who should be annually vaccinated against influenza who live with or care for persons at high risk for influenza-related complications. * History of influenza vaccination within 6 months prior to study enrollment or unwillingness to forego seasonal influenza vaccination during the entire study period. * History of vaccination with an investigational pandemic influenza vaccine other than an 2009 H1N1 Pandemic (H1N1pdm09) vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Infection with human immunodeficiency virus regardless of clinical stage of immunodeficiency. * History of current infection with hepatitis B virus or hepatitis C virus regardless of clinical presentation. * History of or current autoimmune disease. * Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling. * History of Guillain-Barré syndrome. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Hypersensitivity to latex. * Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period. * Pregnant or lactating female. * Female planning to become pregnant or male planning to father a child or either planning to discontinue contraceptive precautions. * Current smoker. * During screening, have a positive test for opiates without a prescription. * History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination. * Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. * Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination. * Blood donation or planned blood donation within 30 days prior to the study vaccination through 30 days after the last blood drawn for this study. * Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity. * Any hematological or biochemical parameter that is out of range of normal, and is considered clinically significant by the investigator.