View clinical trials related to Influenza Vaccines.
Filter by:Background: 1. Burden: Health-care workers (HCWs), such as doctors, nurses, and support staff involved in direct or indirect patient care, are at increased risk of influenza virus infections. HCWs may also transmit and spread influenza among hospitalized patients and other caregivers. HCWs often (40-83%) work while experiencing influenza-like illness (ILI), increasing the likelihood of influenza transmission to colleagues and patients. 2. Knowledge gap: Despite the World Health Organization recommendation for seasonal influenza vaccination among priority target groups such as health care workers, the low-income country such as Bangladesh lacks a seasonal influenza vaccination policy among this high-risk group, and vaccine uptake remains low. 3. Relevance: This study aims to generate preliminary data on HCWs willingness to get seasonal influenza vaccines following vaccine availability and factors associated with vaccine uptakes. The data from the study will support policymakers to increase awareness and develop influenza vaccination policy among top priority groups such as health care workers. Hypothesis: The investigators hypothesize that awareness and availability of influenza vaccine supply would increase influenza vaccine uptake among health care workers Objectives: 1. To assess influenza vaccine uptake among healthcare workers (HCWs) following awareness and availability of influenza vaccine supply in study hospitals 2. To explore HCWs barriers and Motivators for influenza vaccine uptake 3. To understand policy makers' perspectives on the feasibility of influenza vaccination among HCWs and to share with the National Immunization Technical Advisory Group (NITAG) for a policy decision regarding influenza vaccination Methods: The study will be conducted at four tertiary-level public teaching hospitals in Bangladesh. The investigators will use a cluster randomized controlled trial design. The intervention will be randomly allocated at the facility level and will include four arms: i) availability of influenza vaccine supply; ii) influenza vaccine awareness; iii) both influenza vaccine supply and influenza vaccine awareness, and iv) control arm with no intervention. The investigators will assess influenza vaccine uptake before and after intervention and between different study arms. The investigators will also explore the barriers and motivators of vaccine uptake using a qualitative approach. To understand the policy makers' perspectives and opinions regarding influenza vaccination among health care workers, the investigators will conduct in-depth interviews. Outcome measures/variables: 1. The proportion of influenza vaccine uptake among health care workers before and after intervention and between different study arms 2. Different motivators and barriers to influenza vaccine uptake
The main objective of this study was to evaluate the immunogenicity and safety of the booster dose of COVID-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. A randomized controlled, open trial design was adopted. The study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. A total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, 300 in the adult group (18-59 years old) and 300 in the elderly group (60 years old and above); (2) 2400 healthy subjects were selected for the observational study of the safety of co-immunization, 1200 in the adult group (18-59 years old) and 1200 in the elderly group (60 years old and above ) 1200 people.
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.
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.
A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).
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.
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.
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.
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.
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.