View clinical trials related to Influenza, Human.
Filter by:A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months. A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart. Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered. Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection. Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
This study is designed as an international, prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/Flu A&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in human mid-turbinate nasal swabs collected by a trained health worker. This study is part of the performance evaluation to support the CE conformity assessment procedures.
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD [adults ≥ 65 years of age only], or RIV4) in adults 18 years of age and older.
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.
Pregnant women and children with chronic medical conditions are at increased risk of hospitalisation, intensive care admission and death from influenza and COVID-19 infections. However, there appears to be a high level of vaccine hesitancy among women of reproductive age. We will develop "nudge" interventions to improve influenza and COVID vaccine uptake and test the effectiveness of the interventions using randomised controlled trials in - pregnant women - medically at risk children.
VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age. The study duration for each participant will be approximately 13 months.
The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either: - qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations - qIRV (22/23) at dose level 1, - qIRV (22/23) at dose level 2, or - bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV). Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).
Maximum isometric grip strength (MIGS) is a cost-effective, easily accessible, valid and reliable outcome measure for assessing upper body strength in both, adults and children. The the JAMAR Hydraulic Hand Dynamometer is the current gold standard for measuring MIGS. For certain age- and activity-groups, alternative devices may be more appropriate. To date, the quality criteria (test-retest-reliability and validity) of the JAMAR Smart Hand Dynamometer and the Martin Vigorimeter compared to the current gold standard are not yet investigated. Furthermore, no reference values for different age-, sex-, or activity level groups exist with regard to underlying disease entities for these three devices.