23 Clinical Trials for Various Conditions
The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered in healthy adults 18 to 85 years of age.
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects
The aim of the present dose ranging study is to evaluate the safety, tolerability and immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.
The purpose of this research study is to compare how the body reacts to different strengths of an H5N1 flu vaccine when given by different routes of injection (injection into the skin or into the muscle). It will also compare how antibodies (proteins produced by the body's immune system that recognize and help fight infections and other foreign substances in the body) are made after receiving the H5N1 flu vaccine. Participants will include 100 healthy adults, ages 18-40 years. Study procedures include blood samples and completing a memory aid documenting daily oral temperature and side effects for 7 days following each vaccination. Participants may be involved in the study for up to 13 months.
This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89_18 in the \<65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH5N1c) followed by one or two booster vaccinations with a MF59-adjuvanted H5N6 cell culture derived vaccine (aH5N6c) 3 weeks apart elicit immune responses to the antigens used for priming (H5N1) and boosting (H5N6) after first and second heterologous booster vaccination. Eligible subjects, who received 2 doses of aH5N1c in the parent study V89_18 are randomized in a 1:1 ratio to receive either two aH5N6c vaccinations, 3 weeks apart (group 1) or an aH5N6c vaccination on Day 1 and saline placebo on Day 22 (group 2). Eligible subjects, who received placebo in the parent study will receive two aH5N6c vaccinations, 3 weeks apart (group 3). After the second vaccine administration, subjects are monitored for approximately 6 months for safety and antibody persistence. The total study duration will be approximately 7 months per subject.
This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.
The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.
This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to \<65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.
The purpose of this study is to characterize the immunogenicity and safety of 3 doses of GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18 years or greater who are at increased occupational risk of H5N1 exposure.
The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies. The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.
This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).
The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.
The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged \>=18 years. This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.
This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will be performed in two parts. In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A Safety Review Committee (SRC)will review all safety data, including laboratory values, through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments are considered safe, Part 2 of the study will be initiated and a second vaccination will be administered to subjects in Part 1 on Day 21. In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same visit structure and protocol-defined requirements as subjects in Part 1, without the additional laboratory safety measurements. An SRC review will also be performed of all safety data through the Day 28 visit for subjects participating in Part 1.
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.