Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3169 | Quadrivalent RIV with 2018-2019 NH H3 strain Wiki | 1.00 |
| drug3174 | Quadrivalent RIV with H3 strain 2 and adjuvant Wiki | 1.00 |
| drug3172 | Quadrivalent RIV with H3 strain 1 and adjuvant Wiki | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
The primary objectives of the study are: - To describe the safety profile of the different formulations in all participants - To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives are: - To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). - To describe SN antibody responses in each group against each of the H3 antigens. - To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group. - To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.
Description: Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Measure: Number of participants with immediate adverse events Time: Within 30 minutes after vaccinationDescription: Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Measure: Number of participants with solicited injection site or systemic reactions Time: From Day 0 to Day 7Description: Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
Measure: Number of participants with unsolicited adverse events Time: From Day 0 to Day 28Description: Serious adverse events are collected throughout the study
Measure: Number of participants with serious adverse events Time: From Day 0 to Day 365Description: Adverse events of special interest are collected throughout the study
Measure: Number of participants with adverse events of special interest Time: From Day 0 to Day 365Description: Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
Measure: Clinical safety laboratory test results Time: From Day 0 to Day 7Description: Influenza antibody titers are measured by HAI and SN assays
Measure: HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine Time: From Day 0 to Day 365Description: Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
Measure: Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine Time: From Day 0 to Day 90Description: Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)
Measure: Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine Time: From Day 0 to Day 28Description: Influenza vaccine antibody titers are measured by HAI assay
Measure: HAI Ab titer ≥ 40 [1/dil] Time: From Day 0 to Day 365Description: Influenza vaccine antibody titers are measured by SN assay
Measure: 2-fold and 4-fold increase in SN titers Time: From Day 0 to Day 28Description: Influenza vaccine antibody titers are measured by HAI and SN assays
Measure: HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens Time: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365Description: Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0
Measure: Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens Time: From Day 0 to Day 90Description: Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)
Measure: Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations Time: Day 0 and Day 28Description: Influenza vaccine antibody titers a are measured by SN assay
Measure: 2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens Time: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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