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Influenza, Human clinical trials

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NCT ID: NCT02950688 Withdrawn - Influenza, Human Clinical Trials

Safety and Effectiveness of a Seasonal Live Attenuated Influenza Vaccine in a Human Challenge Model of Infection With Wild-type (wt) Influenza A/California/2009 (H1N1)-Like Virus

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the immune response produced by a seasonal live attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will be followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical response, and viral shedding after exposure to the wild-type A/California/2009-like influenza challenge virus.

NCT ID: NCT02883972 Withdrawn - Influenza, Human Clinical Trials

Childhood Influenza Immunisation Invitation Trial in Schools

Start date: September 2016
Phase: N/A
Study type: Interventional

This study will investigate whether influenza vaccine uptake by school-age children (in school-based clinics) can be increased by making behavioural-insight informed changes to the invitation process which encourage parents to return consent forms.

NCT ID: NCT02177734 Withdrawn - Influenza Clinical Trials

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age

Start date: March 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.

NCT ID: NCT02037282 Withdrawn - Influenza Clinical Trials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....

NCT ID: NCT01992276 Withdrawn - Influenza Clinical Trials

Assessment of Efficacy of CR8020 and CR6261, Monoclonal Antibodies, Against Influenza Infection

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

The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection

NCT ID: NCT01810731 Withdrawn - HIV Clinical Trials

Safety and Immunogenicity Study of Influenza Vaccines in HIV-infected and HIV-uninfected Pregnant Women in Western Kenya

Start date: April 2014
Phase: Phase 2/Phase 3
Study type: Interventional

In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are the most important risk group for season influenza vaccination based upon "compelling evidence of substantial risk of severe disease in this group and evidence that seasonal influenza vaccine is safe and effective in preventing disease in pregnant women as well as their young infants, in whom disease burden is also high". Recent data from Kenya, similarly suggest rates of influenza-associated hospitalizations in children under age 1 to be as high, or higher, than those observed in the United States. However, TIV may have reduced immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a double-blind randomized controlled trial of influenza vaccines stratified by HIV status in up to 720 pregnant women in their second and third trimesters and their infants residing in health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal influenza vaccination policies in Kenya and other African countries.

NCT ID: NCT01623232 Withdrawn - Aged Clinical Trials

MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly

CCTA #0005
Start date: October 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed, unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be assessed.

NCT ID: NCT01546935 Withdrawn - Influenza Clinical Trials

Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One

Start date: December 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one. There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.

NCT ID: NCT01270685 Withdrawn - Influenza Clinical Trials

2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies

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

The purpose of this study is to evaluate specific approaches used to prevent/reduce influenza transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, including assessing infection control strategies used by SCI staff and guidance provided by local infection control units. Due to the rapid spread of and uncertainties about the H1N1 virus, we will evaluate patient's beliefs, behaviors, and information seeking strategies (e.g., social media). These findings will lend to the understanding of ways to handle emergent issues, such as the H1N1 pandemic, in special populations.

NCT ID: NCT01150149 Withdrawn - Influenza Clinical Trials

Evaluating Modes of Influenza Transmission Between Humans

Start date: March 2009
Phase: N/A
Study type: Interventional

Most countries of the world, including the USA are making preparations for a possible influenza pandemic. Such an event will constitute a global public health emergency, but it is impossible to predict when this will happen. Up to 80 million people could die worldwide, so as much as possible needs to be done in advance to find ways of how the impact can be reduced. Although the investigators know that medical interventions such as anti-influenza drugs and antibiotics will be important, even in well resourced countries these might be in short supply. Vaccines will also be important but these will not be available until at least 4-5 months after the pandemic has started. This means that other non-pharmaceutical measures could well be important such as social distancing, school closures and the use of face masks. Guidance also needs to be developed so that families can care for each other whilst minimizing the spread of infection. To do these things, the investigators need to know how influenza is transmitted from person-to person. This is poorly understood at present. The investigators also need to know if face masks work before recommendations for public use can be made. The best way to study influenza transmission and the effectiveness of masks is to perform a study using healthy adult volunteers. The investigators will do this by giving some volunteers normal influenza via nasal drops. When they get symptoms the investigators will create an 'experimental household' by getting them to live with other non-infected volunteers for 48 hours, in a specially designed quarantine isolation unit. Some of the non-infected volunteers will be unprotected; others will be selected randomly to wear either face masks or a special plastic 'cloak' so that they do not touch their faces; another group will wear both. The investigators will then measure the rate at which the different groups get 'flu'. From these data the investigators can work out whether it is touching the face or coughing and sneezing that spreads flu most or whether both are important; the investigators can also deduce how well face masks work to prevent spread. The investigators need almost 2000 volunteers for this study, it will take at least 2 years to complete and it will be very costly, however, the results will be of global importance. If the study is successful, the investigators can tell governments around the world whether face masks work to prevent influenza and be clearer about the guidance that should be given to families.