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Influenza, Human clinical trials

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NCT ID: NCT02550197 Completed - Influenza Clinical Trials

Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years

Start date: September 2015
Phase: Phase 3
Study type: Interventional

The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety. Objectives: - To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed. - To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations

NCT ID: NCT02549365 Completed - Clinical trials for Influenza Vaccines Efficacy and Safety

Efficacy & Safety of Nasal Influenza Immunisation in Children

SNIFFLE-3
Start date: October 2015
Phase: Phase 4
Study type: Interventional

The UK Departments of Health now recommend annual influenza vaccination for all children 2-7 years of age, with children over 7 years eligible for vaccination if in certain higher risk clinical categories. Though data are available documenting the safety and immunogenicity of LAIV in this age group, there are little data to assess efficacy and immune correlates in UK children, and in particular atopic children. This study will enrol 200 children (and at least 200 unvaccinated household sibling controls), many with a history of asthma or recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in these children, and how this varies with prior administration of pandemic influenza vaccine and/or LAIV.

NCT ID: NCT02547792 Completed - Clinical trials for Seasonal Influenza B

Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults

Start date: October 20, 2015
Phase: Phase 1
Study type: Interventional

This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27 subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated through 1 year post vaccination.

NCT ID: NCT02545543 Completed - Influenza, Human Clinical Trials

A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age

Start date: September 2015
Phase: Phase 3
Study type: Interventional

This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.

NCT ID: NCT02532283 Completed - Influenza A Virus Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

Start date: December 11, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.

NCT ID: NCT02529904 Completed - Influenza Clinical Trials

ADITEC FLU 2 STUDY: Understanding the Genetics Basis for Immune Responses to Flu Vaccines in Children and Adults

Start date: August 2015
Phase: Phase 2
Study type: Interventional

Influenza infection is related to significant morbidity and mortality in children. The trivalent inactive vaccine (TIV) has been documented to have poor immunogenicity in children and the live attenuated influenza vaccine (ATIV) although proven to have more efficacy is unable to be administered to children under 2 years old. The MF59 adjuvanted influenza vaccine as proven efficacy on reducing the rates of laboratory confirmed influenza, including in children. The study aims to assess early gene transcriptional responses to priming and boosting with MF59-ATIV in children aged 13-24 months and adults aged 18 - 65 years, and to establish correlations with haemagglutination inhibition (HAI) titers. It will be an open label study with 90 healthy children allocated to 3 groups (groups 1, 2 and 3) and 30 healthy adults allocated to group 4.

NCT ID: NCT02525055 Completed - Influenza Clinical Trials

Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model

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

The 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.

NCT ID: NCT02523287 Completed - Clinical trials for Safety Markers of Adjuvanted Influenza Vaccine

Placebo Controlled Study to Generate Data Characterising Clinical Events, Physiological Responses and Immune Responses

Start date: October 2, 2014
Phase: Phase 4
Study type: Interventional

The 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.

NCT ID: NCT02522754 Completed - Influenza Clinical Trials

Development of an Intranasal Proteosome Influenza Vaccine

Start date: January 2002
Phase: Phase 1/Phase 2
Study type: Interventional

A study to compare multiple dosage regimes of a protesomal intranasal vaccine.

NCT ID: NCT02487173 Completed - Influenza A Clinical Trials

Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

Start date: September 2015
Phase: N/A
Study type: Interventional

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). The secondary aims are to: - validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). - assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A; - assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B; - evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms; - evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test; - evaluate the subjects' comprehension of the Respirio Flu Test labelling; and - establish the minimum sample weight required to achieve a result with the Respirio Flu Test.