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Influenza clinical trials

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NCT ID: NCT02124096 Completed - Influenza Clinical Trials

Zoonotic Influenza Infections of Swine Origin at Ohio Agricultural Fairs

Start date: April 25, 2014
Phase:
Study type: Observational

Background: - The flu is a very infectious and contagious virus that affects both people and pigs. Studies show that pigs can be sources of the flu virus in humans. Researchers want to know more about how the flu is transmitted from animals to people. If they know more about it, they can find better ways to prevent the flu and treat people who get sick from it. Objective: - To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural fairs. Eligibility: - Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs. Design: - Before or on the first day of the fair, participants will fill out a short demographic and medical history form. They will also complete a two-page symptom questionnaire. This is a form that asks them about any flu symptoms they might have. - Participants will have a nasal swab performed. The inside of the participant s nose will be rubbed with a swab to collect nasal fluid. - Researchers will see participants 2 days later and 4 days later. During these visits, participants will again fill out a symptom questionnaire and have a nasal swab.

NCT ID: NCT02121782 Completed - Influenza Clinical Trials

A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)

Start date: May 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in Korean healthy adults. The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV) including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B). However, two antigenically distinct lineages of influenza B (Victoria and Yamagata) co-circulate annually in the United States. Predicting which lineage of influenza B will predominate during a season is challenging, and cross-protection by immunization against the other lineage is expected to be low. One proposed alternative is to produce a quadrivalent influenza vaccine (QIV) including an influenza B virus from each of the two circulating lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4 vaccine components WHO recommends for use in the 2013-14 influenza season (northern hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the additional public health benefit compared with traditional TIV.

NCT ID: NCT02111252 Completed - Influenza Clinical Trials

A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants

NCT ID: NCT02107807 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

Start date: April 2014
Phase: Phase 3
Study type: Interventional

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.

NCT ID: NCT02100436 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Pediatric Populations

Start date: June 11, 2014
Phase: Phase 2
Study type: Interventional

This is a Phase II open-label study in approximately 240, and up to 400, healthy males and non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100 subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately 60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100 subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as 7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject will be approximately 7 months.

NCT ID: NCT02069496 Completed - Influenza Clinical Trials

Drug Use Investigation for Arepanrix® (H1N1)

Start date: February 2010
Phase: N/A
Study type: Observational

This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection. The following items will be investigated as priority investigation items. <Priority investigation items> 1. Allergic reactions 2. Anaphylaxis

NCT ID: NCT02062281 Completed - Influenza Clinical Trials

Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults

Start date: November 2013
Phase: Phase 4
Study type: Interventional

The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs), meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children and adults. The main objective of this study is to show that both vaccines can safely be administered together without affecting the immune response of protecting against disease.

NCT ID: NCT02056340 Completed - Influenza Clinical Trials

Statin Therapy in Acute Influenza

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in the United States and causing as many as 500,000 deaths worldwide each year. Currently, there are only a few treatments for influenza infection and none of these target inflammation that can be caused by the virus. This study will test whether the anti-inflammatory effects of statins, a class of drugs most often used to treat high cholesterol, will decrease the severity of illness in patients who are infected with influenza by testing markers of inflammation in the blood and recording resolution of influenza illness.

NCT ID: NCT02045472 Completed - Influenza Clinical Trials

A Study of VIS410 to Assess Safety and Pharmacokinetics

Start date: September 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.

NCT ID: NCT02037282 Withdrawn - Influenza Clinical Trials

A Phase 1, Open Label, Ascending Dose Cohort Study of the Pharmacokinetics of Anti-Influenza Hyperimmune Intravenous Immunoglobulin in Healthy Subjects

Start date: January 3, 2014
Phase: Phase 1
Study type: Interventional

Despite currently available antivirals, influenza causes significant morbidity and mortality, with 226,000 excess hospitalizations and 30,000-50,000 deaths each year in the United States alone, and more therapies are needed in the armamentarium of anti-influenza medications including humoral immunity-based agents. This study will evaluate the pharmacokinetics of an anti-influenza hyperimmune intravenous immunoglobulin. Beginning with a low dose, subjects will receive anti-influenza intravenous immunoglobulin (FLU-IVIG) and evaluated on Study Days 0, 3, 7, 14, and 28. The safety and tolerability is evaluated using symptoms, clinical laboratory tests, and pharmacokinetics. Utilizing serum antibody responses as determined by hemagglutination inhibition (HAI) assays, the dose will be escalated as immunogenicity is established....