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Quadrivalent RIV with H3 strain 2Wiki

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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
drug1962 Quadrivalent RIV with 2018-2019 NH H3 strain 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)