Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
This randomized, partially-blinded, active comparator-controlled will be conducted at multiple sites. The composition of QVLP to be used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and will be based on the 2020-2021 influenza virus strains. Approximately 400 healthy male and female subjects 65 years of age and older will be enrolled evenly into one of eight parallel treatment groups and subjects will be stratified by age into two groups (65 to 74 years of age and 75 years of age and older) in a 2:1 ratio. Three dose levels of QVLP (15 µg/strain, 30 µg/strain, and 45 µg/strain) will be tested with the adjuvant AS03. The 30 µg/strain is the full dose of QVLP and the 15 µg/strain dose has been included to assess a possible dose-sparing effect in combination with the adjuvant AS03. Subjects will participate in this study approximatly 12 months, during which a first visit will be scheduled on Day 0 for screening and vaccine administration.
Description: Percentage, intensity and relationship to vaccination of immediate adverse events (AEs)
Measure: Immediate adverse event (AEs) Time: 30 minutesDescription: Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following vaccination
Measure: Solicited local and systemic adverse events (AEs) Time: Day 7Description: Percentage, intensity and relationship of unsolicited adverse events (AEs) following vaccination
Measure: Unsolicited adverse events (AEs) Time: Day 28Description: Number and percentage of subjects with normal and abnormal, clinically significant urine, haematological and blood biochemistry values, and urinalysis
Measure: Safety labs Time: Day 28Description: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse events of special interest (AESIs), medically attended adverse event (MAAEs), new onset of chronic disease (NOCDs) and deaths from day 183 up to the end of the study (day 365)
Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse events of special interest (AESIs), medically attended adverse event (MAAEs), new onset of chronic disease (NOCDs) and deaths Time: Day 0 to 365Description: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strains on Day 28, compared to Day 0 values. HI antibody titers will be analyzed using the following parameters: geometric mean titers (GMT), seroconversion (SC) rate, seroprotection (SP) rate, and geometric mean fold rise (GMFR).
Measure: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strain Time: Day 28Description: MN antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strains on Day 28, compared to Day 0 values. MN antibody titers will be analyzed using the following parameters: GMT, SC rate, and GMFR
Measure: MN antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strains Time: Day 28Description: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the heterologous influenza strains on Day 28, compared to Day 0 values. HI antibody titers will be analyzed using the following parameters: GMT, SC rate, SP rate, and GMFR
Measure: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the heterologous influenza strains Time: Day 28Description: Durability of antibody responses, as determined by HI and MN titers against homologous influenza strains (6 and 12 months post-vaccination)
Measure: Durability of antibody responses Time: 12 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports