Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers
Influenza AThe primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies. Illness parameters were collected by subject symptom scores as well as by physical examination. Virus parameters were measured by PCR and cell culture assay (performed by VisMederi srl).
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013
InfluenzaThis study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial...
Reminder SystemsInfluenza VaccinesThis 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.
Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model
InfluenzaThe study will characterise Influenza A/Perth/16/2009(H3N2) virus in healthy participants using the viral challenge model. The study includes two cohorts. Cohort 1: A randomised, double-blind study of 4 titres of Challenge Virus to determine the optimum titre. Cohort 2: An open-label extension arm in which all participants will receive the 'optimum' titre as identified from Cohort 1.
Placebo Controlled Study to Generate Data Characterising Clinical Events, Physiological Responses...
Safety Markers of Adjuvanted Influenza VaccineThe purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. 240 healthy participants (18-45y) will be enrolled, 228 will be administered a dose of Fluad on Day 0, 12 will receive a placebo on Day 0.
Increasing the Uptake of Influenza and Pneumococcal Vaccines Among High-Risk Adult Patients Through...
Immunization ProgramsPneumonia and influenza are among the top causes of hospitalisation and death in the elderly. While vaccinations are recommended against these diseases, a large proportion of elderly in the community remain unvaccinated, with approximately only 10% vaccinated for either disease. In this study, the investigators aim to implement an intervention package within GP clinics to increase influenza and pneumococcal vaccination rates, especially among elderly patients with chronic diseases.
Safety Study of Seasonal Influenza Vaccine by Jet Injection
Healthy AdultsThis research study involves testing of a device that can give injections (shots) without the use of a needle.
Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During...
InfluenzaThe main purpose of this study is to assess the potential exposure of neonates to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.
Nontypeable H. Influenzae in Healthy Adults
Haemophilus Influenzae (NTHI)The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae, its ability to produce adverse reactions and to live in the nose and throat. The nose and throat of healthy adults will be populated with a specific type of H. influenzae Nontypeable Haemophilus influenzae (NTHi) 2019 Streptomycin Resistant (StrR) number 1. Researchers will study whether the germ settles in the nose and throat, whether it causes symptoms after it has been placed in the nose, how long the germs last in the nose and throat, and whether the body tries to produce a permanent defense to the germ. Volunteers will receive a lower dose (3,200 germs) or a higher dose (32,000 germs). Active participation will last about 28 days, including a 3 night hospital stay, additional follow-up visits, followed by a 6 month follow-up phone call. Study procedures will include blood samples, saliva samples, several nose washes and throat swabs.
Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
InfluenzaThis will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.