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Influenza Vaccines clinical trials

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NCT ID: NCT04038333 Completed - Influenza, Human Clinical Trials

Financing Strategies of Influenza Vaccination in China

Start date: August 1, 2019
Phase:
Study type: Observational

This trial focuses on influenza vaccination among three recommended groups in China. Data concerning the economic burden of influenza-like illness (ILI), vaccine hesitancy, discrete choice experiment, immunization records and willingness to pay for vaccines will be collected via questionnaires, and the financing strategies of influenza vaccines in China will be further analyzed. Besides, the knowledge, attitude/belief and practice (KAP) of medical staff will also be asked in a supplementary questionnaire.

NCT ID: NCT03735147 Completed - Influenza Vaccines Clinical Trials

Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children

FluSHED-2
Start date: October 23, 2018
Phase: Phase 4
Study type: Interventional

LAIV shedding studies in children could be an important way to confirm whether impediments to viral replication do indeed explain these observed reductions in vaccine effectiveness (VE), whether prior vaccination has any influence on replication and what future implications (if any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children will be dependent on virological and host factors. The virus factors include replicative fitness of individual strains and the susceptibility to inhibition by other replicating strains (ability to compete). Host factors which may influence this include pre-existing specific immunity as a result of prior infection or previous vaccination (with either LAIV or IIV), and innate immune factors including mucosal immunity. There is significant variability in shedding across viral subtypes in studies done to date, so there is a need to obtain local data in a small pilot observational study which will look in detail at virus shedding by sequential daily virus samples, something not possible on a larger scale. The data generated will inform future LAIV studies in the UK in terms of optimum time of sample collection for viral shedding studies, which are likely to be required on a regular basis, to supplement field studies of vaccine effectiveness. This study will enrol up to 30 children that will allow these factors to be assessed. Both written informed consent from parent/ guardian and written assent from the child will be in place prior to any study procedure. All participants will have a baseline assessment of pre--existing influenza immunity (blood test, oral fluid collection and nasal swabs), followed by a single dose of LAIV. Parents will then be asked to take nasal swabs at home on days 1, 2, 3, 4, 5, 6, 7, 8, with further nasal swab, blood test and oral fluid collection in hospital 4 weeks later, in order to assess for immune responses to LAIV.

NCT ID: NCT03246100 Completed - Influenza Vaccines Clinical Trials

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado

Start date: September 6, 2017
Phase: N/A
Study type: Interventional

This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are slight changes to methods and a different cohort will be used, thus justifying a 2nd ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in Colorado. Each state has it's own ClinicalTrials.gov submission. Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall versus 3) usual care (no R/R) on improving influenza vaccination rates. The investigators will disseminate the state immunization information system based reminder/recall system to all states for use for both seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

NCT ID: NCT03057483 Completed - Influenza Vaccines Clinical Trials

Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute

FLU-05-IB
Start date: April 6, 2017
Phase: N/A
Study type: Observational

Rationale and background: Since 2013, IB has been performing passive pharmacovigilance activities related to TIV. Objetive: To implement an active surveillance study as part of our pharmacovigilance plan while passive surveillance activities will continue. Pharmacovigilance data on TIV, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of TIV. Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: children between six months and five years old; pregnant women; postpartum women (mothers until 45 days after birth); healthcare workers; and elderly (people over 60 years old). Study Size: A total of 900 individuals (300 health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children between six months and five years old), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent. Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate.

NCT ID: NCT02831608 Completed - Stroke Clinical Trials

Study on the Effect of Influenza Vaccination After Heart Attack on Future Cardiovascular Prognosis

IAMI
Start date: October 2016
Phase: Phase 4
Study type: Interventional

Background. For more than a century a causal link between influenza and cardiovascular disease has been suspected. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. Accordingly, registry studies, case control studies and a few small randomized trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute myocardial infarction (AMI) is increased following respiratory infection and that the risk of stroke and AMI in patients with established cardiovascular disease seem to be reduced following influenza vaccination. In May 2015 a Cochrane review concluded that influenza vaccination may reduce cardiovascular mortality and cardiovascular events but bias and inconsistent results in prior studies require higher-quality evidence to confirm these findings. High costs and little commercial interest in conducting a randomized trial on influenza vaccine in cardiovascular disease stand in the way. Objective. The objective is to document whether influenza vaccination protects against cardiovascular events and death in patients with an AMI or very high risk stable coronary artery disease patients. Methods. Population: 4400 patients with ST-elevation (STEMI), non-ST elevation myocardial infarction (NSTEMI) or very high risk stable coronary artery disease are randomized 1:1 in a blinded fashion using an RRCT design and followed up via registries and telephone calls. Intervention: Influenza vaccination. Control: Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial infarction and stent thrombosis till 1 year. Patients will be included in the study in all of Sweden's 7 university hospitals and 5 general hospitals, 4 university hospitals and 1 general hospital in Denmark, in 1 specialized heart center in Norway, 2 university hospitals in Czech Republic, 6 hospitals in Scotland, 1 university hospital in Latvia and 2 hospitals in Bangladesh. Secondary endpoints are time to all-cause death till 1 year, time to cardiovascular death till 1 year, time to stent thrombosis till 1 year, time to revascularization till 1 year, time to myocardial infarction till 1 year, time to cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year, time to stroke, including TIA till 1 year, time to rehospitalization for heart failure till 1 year, time to hospitalization for arrhythmia till 1 year or length of hospital stay (if information is available). From a hypothesis generating perspective we aim to follow up patients through registries beyond 1 year and up to 5 years. The trial has been approved by the ethical committee system (Dnr 2014/264) and the Medical Products Agency (EudraCTnr -2014-001354-42) in Sweden. Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza vaccination may become an important novel in-hospital therapy for patients with cardiovascular disease and the accompanying direct and indirect societal gains will be profound.

NCT ID: NCT02761551 Completed - Influenza Vaccines Clinical Trials

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The investigators will disseminate the state immunization information system based reminder/recall system to all states for use for both seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

NCT ID: NCT02560909 Completed - Transplantation Clinical Trials

Adjuvanted Influenza Vaccine in Stem Cell Transplant

Start date: October 2015
Phase: Phase 4
Study type: Interventional

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity. There are no studies that define the effect of adjuvanted vaccine in this population. The purpose of this study is to determine if a vaccination with FLUAD® results in improved immunogenicity as compared to standard vaccine in allo-HSCT recipients. Immunogenicity will be assessed by standard quantitative antibody titer assessments and using cell-mediated immunity measurements.

NCT ID: NCT02358083 Completed - Influenza Vaccines Clinical Trials

Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents

Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (HPV) or Influenza.

NCT ID: NCT01788228 Completed - Influenza Clinical Trials

Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

Start date: March 22, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.

NCT ID: NCT01310413 Completed - Influenza Clinical Trials

Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age

Start date: March 7, 2011
Phase: Phase 3
Study type: Interventional

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to < 18 years of age.