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Children and people infected with HIV are particularly susceptible to influenza infections. This study will test the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
The new H1N1 influenza virus seen in 2009 has been designated a pandemic by the World Health Organization, due to the sustained community outbreaks seen in the United States and Mexico. Based on preliminary data, it appears children and young adults are particularly at risk of the H1N1 virus. People infected with HIV are also more susceptible to severe influenza infections than those who are uninfected. Children with HIV infection, then, have a compounded risk of H1N1 infection. Higher doses of influenza vaccines are associated with the development of higher levels of serum antibodies, which are needed to resist infection. Higher vaccine doses can be used to improve vaccine effectiveness in at-risk populations. This study will test the safety and immune response of HIV infected children and youth to a high dose of a vaccine for the new H1N1 influenza virus.
Participation in this study will last 7 months and have two steps. The first step involves receiving the first dose of H1N1 virus vaccine, and the second step, occurring 21 days later, involves receiving the second dose of vaccine. Each dose of vaccine will be delivered via two intramuscular shots (four total injections). After receiving each dose of the vaccine, participants will be given a diary to record any symptoms or reactions. Participants will be stratified into three groups by age, including 4 to 9 years, 9 to 18 years, and 18 to 25 years.
Participants will complete five scheduled visits, taking place at screening, study entry, Days 21 and 31, and after 7 months. Measurements taken on these visits will include a medical history, physical and neurological exams, a blood draw, and, when applicable, a pregnancy test. In addition to these visits, participants may receive up to three additional phone calls or visits occurring 2 and 10 days after the first dose of vaccine and 2 days after the second dose of vaccine to check for reactions to the vaccine.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Influenza A (H1N1) 2009 monovalent vaccine
University of Alabama Birmingham NICHD
Not yet recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-27T03:18:46-0400
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The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults
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