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Quadrivalent RIV with 2018-2019 NH H3 strainWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug1964 Quadrivalent RIV with H3 strain 1 Wiki 1.00
drug1965 Quadrivalent RIV with H3 strain 1 and adjuvant Wiki 1.00
drug1967 Quadrivalent RIV with H3 strain 2 and adjuvant Wiki 1.00
drug1963 Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant Wiki 1.00
drug1966 Quadrivalent RIV with H3 strain 2 Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D007251 Influenza, Human NIH 0.30

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects

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.

NCT04451954 Influenza Biological: Quadrivalent RIV with H3 strain 1 Biological: Quadrivalent RIV with H3 strain 1 and adjuvant Biological: Quadrivalent RIV with H3 strain 2 Biological: Quadrivalent RIV with H3 strain 2 and adjuvant Biological: Quadrivalent RIV with 2018-2019 NH H3 strain Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
MeSH:Influenza, Human

Primary Outcomes

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 vaccination

Description: 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 7

Description: 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 28

Description: Serious adverse events are collected throughout the study

Measure: Number of participants with serious adverse events

Time: From Day 0 to Day 365

Description: 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 365

Description: 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 7

Description: 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 365

Description: 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 90

Description: 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 28

Description: Influenza vaccine antibody titers are measured by HAI assay

Measure: HAI Ab titer ≥ 40 [1/dil]

Time: From Day 0 to Day 365

Description: 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 28

Secondary Outcomes

Description: 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 365

Description: 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 90

Description: 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 28

Description: 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 365

No related HPO nodes (Using clinical trials)