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H5N1 clinical trials are clinical trials concerning H5N1 vaccine; which is to say they are investigations concerning H5N1 vaccine in humans intended to discover pharmacological effects and identify any adverse reactions. IFPMA glossary
Revaccination - January 2006
Study completion: January 2006
The purpose of this study is to determine whether having received an H5 vaccine in the past primes the immune system to respond rapidly to another dose of H5 vaccine. Subjects who participate in this study will have participated in a previous vaccine study (involving the A/Hong/Kong/97 virus) during the fall of 1998 at the University of Rochester. clinicaltrials.gov Revaccination With Subunit Influenza A/Vietnam/1203/2004 (H5N1) Vaccine
A/H5N1 in adult - February 2006
Study start: April 2005; Study completion: February 2006
The purpose of this study is to determine the dose-related safety of flu vaccine in healthy adults. To determine the dose-related effectiveness of flu vaccine in healthy adults approximately 1 month following receipt of 2 doses of vaccine. To provide information for the selection of the best dose levels for further studies. clinicaltrials.gov A/H5N1 Adult - Aventis
H5 booster after two doses - June 2006
Study start: October 2005; Study completion: June 2006
The purpose of this study is to determine whether a third dose of vaccines containing A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this study, will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. In this study, each subject will be asked to receive a third dose of the H5 vaccine at the same level administered in protocol 04-063. clinicaltrials.gov H5 Booster After a Two Dose Schedule
H5 in the elderly - August 2006
Study start: October 2005; Study completion: August 2006
This study is intended to examine the safety and dose-related immunogenicity of three dosage levels of the Influenza A/H5N1 vaccine, as compared to saline placebo, given intramuscularly to healthy elderly adults approximately 4 weeks apart. clinicaltrials.gov H5 Aventis in the Elderly
H5 in healthy adults - November 2006
Study start: March 2006; Expected completion: November 2006
This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection of vaccine dosage levels for expanded Phase II trials based on reactogenicity and immunogenicity profiles. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be enrolled at one of up to 5 study sites and will be randomized into 8 groups to receive two doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or without aluminum hydroxide adjuvant by IM injection (N= 60 or 120/vaccine dose group). clinicaltrials.gov H5 Vaccine Alone or With Adjuvant in Healthy Adults
Bird flu - November 2006
Study start: March 2006; Study completion: November 2006
This study is designed to gather critical information on the safety, tolerability, and the immunogenicity (capability of inducing an immune response) of A/H5N1 virus vaccine in healthy adults. Up to 280 healthy adults, aged 18 to 64, will participate in the study. Each subject will participate for 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine, vaccine plus adjuvant, or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in their muscle tissue. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, and 6 months after the second injection. clinicaltrials.gov H5 Adult - Chiron Study of Bird Flu Vaccine
Pandemic flu - January 2007
Study start: October 2005; Study completion: January 2007
This Australian study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in healthy adults. clinicaltrials.gov Study of a Pandemic Influenza Vaccine
Children - February 2007
Study start: January 2006; Study completion: February 2007
This is a randomized, double-blinded, placebo-controlled, staged, dose-ranging, Phase I/II study to evaluate the safety, reactogenicity, and immunogenicity of 2 doses of an IM inactivated influenza A/H5N1 vaccine in healthy children, aged 2 through 9 years. This study is designed to investigate the safety, tolerability, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 vaccine. A secondary goal is to identify an optimal dosage level of the vaccine that generates an acceptable immunogenic response, while maintaining an adequate safety profile. clinicaltrials.gov H5 Aventis Children 2 - 10
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