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Avian Influenza clinical trials

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NCT ID: NCT02612909 Completed - Avian Influenza Clinical Trials

A Safety and Immunogenicity Study of IVACFLU-A/H5N1

Start date: March 7, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

NCT ID: NCT02295813 Completed - Avian Influenza Clinical Trials

Safety and Pharmacokinetics Study of FBF001

Start date: October 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.

NCT ID: NCT02251288 Completed - Avian Influenza Clinical Trials

A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine

Start date: May 18, 2015
Phase: Phase 1
Study type: Interventional

A phase I prospective, randomized study in healthy adult subjects at a single center. Adult subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group 1), 12 weeks (Group 2), or 24 weeks (Group 3), or to be in an observational group (Group 4) which will not be scheduled for a booster dose but may serve as a roll-over group for subjects who withdraw prior to the second vaccination but agree to remain in follow-up. A fifth group will receive two intramuscular doses of adjuvanted H7N9 pIIV separated by four weeks. The primary objectives of this study are to (1) assess the safety of H7N9 pLAIV administered to individuals who have previously received MF59-adjuvanted or unadjuvanted H7N9 pIIV, (2) evaluate the ability of a single dose of unadjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine, and to (3) evaluate the ability of a single dose of MF59-adjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine.

NCT ID: NCT02229357 Completed - Avian Influenza Clinical Trials

Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine

Start date: June 2014
Phase: Phase 2
Study type: Interventional

This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects

NCT ID: NCT02213354 Completed - Avian Influenza Clinical Trials

H7N9 Mix and Match With MF59 in Healthy Elderly Persons

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

This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males and females, 65 years of age and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. Study Duration is approximately 30 months and Subject Participation is approximately 18 months. The primary objectives are to (1) assess the safety and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuv

NCT ID: NCT01897701 Completed - Avian Influenza Clinical Trials

A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1

Start date: July 2013
Phase: Phase 1
Study type: Interventional

This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups. Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.

NCT ID: NCT01698060 Completed - Avian Influenza Clinical Trials

Immunogenicity of ND1.1 by Delivery Directly to the Ileum

ICC H5
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of ND1.1 oral vaccine.

NCT ID: NCT01675284 Completed - Avian Influenza Clinical Trials

A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine

Start date: August 2012
Phase: Phase 1
Study type: Interventional

The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.

NCT ID: NCT01511419 Completed - Influenza Clinical Trials

Safety Trial of Live Attenuated Influenza (H7N3) Vaccine

Start date: April 2012
Phase: Phase 1
Study type: Interventional

The study hypothesis is that two doses of cold-adapted, live monovalent A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in healthy adults.

NCT ID: NCT01335347 Completed - Avian Influenza Clinical Trials

Safety Study of an Oral Vaccine to Prevent Avian Influenza

H5N1
Start date: April 2011
Phase: Phase 1
Study type: Interventional

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.