Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Vaccination Strategies With Stockpiled Inactivated Monovalent Influenza A(H5) Vaccines Administered Intramuscularly With Either AS03 or MF59® as Adjuvant
Sponsor study identifier
interventional
720
1 country
6
Study Start
March 15, 2018
Actual (reported)Primary Completion
November 19, 2019
Actual (reported)Study Completion
November 19, 2019
Actual (reported)The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 19, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 13, 2018
Actual (reported)March 15, 2018
Actual (reported)April 13, 2018
Actual (reported)November 19, 2019
Actual (reported)November 19, 2019
Actual (reported)July 14, 2020
Actual (reported)Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited local reactogenicity symptoms. Subjects in A-D and G-J did not receive 3 doses
8 days post-vaccination
Number of Systemic Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series
Safety of 2-dose and 3-dose H5 influenza vaccination series as determined by occurrence of mild, moderate, or severe solicited systemic reactogenicity symptoms Subjects in A-D and G-J did not receive 3 doses
8 days post-vaccination
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 2-dose H5 Influenza Vaccination Series
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
Day 43
Percentage of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Seroprotection Against Vaccine Strains Following 3-dose H5 Influenza Vaccination Series
Serum hemagglutination inhibition (HAI) antibody seroprotection rate (SPR)
Day 163
Single dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
Single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Optimal Research
San Diego, California, 92108, United States
Optimal Research
Peoria, Illinois, 61614, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Central Kentucky Research Associates Inc
Lexington, Kentucky, 40509, United States
Optimal Research
Rockville, Maryland, 20850, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
720 participants (actual enrollment reported by the registry).
First Submitted
March 13, 2018
First Posted
April 13, 2018
Study Start
March 15, 2018
Actual (reported)Single dose of dk/Bangladesh (BANG) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
Single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 2 = Day 22).
Two doses of dk/BANG (H5N1) vaccine with AS03 Adjuvant (Dose1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/Qinghai Lake(QL) (H5N1) vaccine with AS03 Adjuvant (Day 142).
Two doses of gf/WA (H5N3) vaccine with AS03 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with AS03 Adjuvant (Day 142)
Single dose of VN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Single dose of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Single dose of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1), followed by single dose of IN (H5N1) vaccine with MF59 Adjuvant (Dose 2 = Day 22).
Two doses of dk/BANG (H5N1) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22); followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
Two doses of gf/WA (H5N8) vaccine with MF59 Adjuvant (Dose 1 = Day 1; Dose 2 = Day 22), followed by single dose of bhg/QL (H5N1) vaccine with MF59 Adjuvant (Day 142).
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 19, 2019
Actual (reported)Study Completion
November 19, 2019
Actual (reported)Last Updated
July 14, 2020
Results First Posted
July 14, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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