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UMB Dataset
Safety, Reactogenicity, and immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant
- Authors
- Wilbur H. Chen
- Description
This multicenter randomized, controlled, double-blind Phase 1 trial investigated the safety, tolerability, immunogenicity, and feasibility of adding an adjuvant to an influenza vaccine at point-of-use (commonly referred to as the Mix-N-Match study). Inactivated influenza A/Indonesia/05/2005 virus vaccine and the adjuvant, AS03, were provided by the US Department of Health and Human Services (HHS) Biomedical...
- Subject
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Vaccines
- Timeframe
- 2011
- Access Rights
- Registration required
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UMB Dataset
Persistance of Antibody to Influenza A/H5N1 Vaccine Virus: Impact of AS03 Adjuvant
- Authors
- Wilbur H. Chen
- Description
The research associated with this dataset is an extension of a multicenter randomized, controlled, double-blind phase 1 trial that investigated combining an adjuvant (AS03) with an influenza (A/H5N1) vaccine at point-of-use (see “Related Datasets” below). In the original study adult volunteers were given 2 intramuscular doses of vaccine containing 3.75, 7.5, or 15 mcg of hemagglutinin (HA) with or...
- Subject
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Vaccines
- Access Rights
- Registration required
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UMB Dataset
Clinical Study Reports (CSR) Used in the Systematic Review of Neuraminidase Inhibitors for Preventing and Treating Influenza in Healthy Adults and Children with Confirmed or Suspected Exposure to Natural Influenza
- Alternate Title(s)
- CSRs used in Cochrane review of neuroaminidase inhibitors for influenza
- Authors
- Peter Doshi
- Description
Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors. A systematic review of the CSRs and other regulatory documents was conducted to determine the potential benefits and harms of oseltamivir (Tamiflu) and zanamivir (Relenza). Outcome measures included time to first alleviation of symptoms,...
- Subject
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Influenza, Human
- Access Rights
- Unrestricted access